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Targeted HealthCare, an oncology-related website, has posted a video of Lauren Pinter-Brown, MD, Clinical Professor, Department of Medicine, Hematology-Oncology, University of California, Los Angeles, discussing the treatment of cutaneous T-cell lymphoma (CTCL), particularly early-stage CTCL. To visit the Targeted Healthcare website and view this informative video, click here: Dr. Pinter-Brown Video
The Cutaneous Lymphoma Foundation will be joining the National Organization for Rare Disorders (NORD) and others around the world in observing World Rare Disease Day on February 28, 2013. On this day, millions of patients and their families will share their stories to focus a spotlight on rare diseases as an important global public health concern.
A rare disease is one that affects fewer than 200,000 Americans. There are nearly 7,000 such diseases affecting nearly 30 million Americans. On Rare Disease Day, people with rare diseases around the world promote awareness of the challenges of living with a rare disease. The global theme for 2013 is “Rare Disorders Without Borders.”
World Rare Disease Day was launched in Europe four years ago and last year was observed in more than 60 nations. It is always observed on the last day of February. On that day, patients and patient organizations will post stories, videos and blogs online and host events to raise awareness of these diseases, which are often called “orphans”.
This year, the observance has special significance in the U.S. because 1983 is also the 30th anniversary of the Orphan Drug Act, which provides incentives to encourage companies to develop treatments for rare diseases, and of NORD, which was established by patient advocates in 1983.
Rare Disease Day 2013 activities in the U.S. will include awareness events at several State Houses, a Rare Disease Research Hall of Fame, a Handprints Across America photo gallery, and an event at the National Institutes of Health (NIH) in Bethesda, MD.
In 1983, the Orphan Drug Act was passed by Congress to create financial incentives for companies to develop treatments for rare diseases. Since then, more than 400 orphan drugs and biologics have been approved by the Food and Drug Administration (FDA). It is estimated that approximately 15 million Americans benefit from these products, but that still leaves millions more with diseases for which there is no approved treatment.
The Cutaneous Lymphoma Foundation was represented at the oversubscribed and well-attended 2013 Blood Cancer Conference convened by the Leukemia and Lymphoma Society on January 26, 2013. Held at the Loews Hotel adjacent to the Dolby Theater and the iconic Grauman's Chinese Theater, over 600 patients and family caregivers attended a day-long program which featured some of the best leukemia and lymphoma specialists in the Los Angeles area including UCLA's Lauren Pinter-Brown, MD, one of the CLF's Medical Advisory Board members.
A CLF information table was staffed by CLF Board Director, Michael W. Young, who had a chance to interact with numerous patients and discuss cutaneous lymphomas, their impact on their daily lives, and some of the wonderful resources available at no cost through the Cutaneous Lymphoma Foundation and the LLS. The closing motivational talk was given by Bruce Hensel, MD, Chief Medical, Health, & Science Correspondent at KNBC- TV in Los Angeles.
The semi-annual meeting of the Regulatory Education and Action for Patients consortium was held in Washington, DC on January 17, 2013. The topics discussed focused on the current political landscape post-election and looking forward over the next two years along with the future of healthcare reform, improper payments in federal safety net programs (Medicare/Medicaid), an update on the patient focused drug development program in progress at the FDA and an update from the REAP workgroups.
Click here to read a recap of the January meeting highlights.
The REAP consortium currently has 53 member organizations across a wide variety of patient advocate groups, all coming together for a common cause - to promote the voice of patients to policy makers and regulators. This consortium began in 2010 with a few organizations and authored one collaborative comment letter to lawmakers, was signed by 6 organizations. By the end of 2012, the consortium had submitted 10 comment letters total, and the last comment letter was signed by 32 groups, including the CLF, who was also a member of the workgroup that developed the response. The comment letter outlined several detailed recommendations for clarity and transparency surrounding the proposed rule published by the Department of Health and Human Services (HHS) that helps consumers shop for and compare non-grandfathered private health insurance options in the individual and small group markets by promoting consistency across plans and protecting consumers by ensuring that plans cover a core package of items and services. Otherwise referred to as Essential Health Benefits.
The REAP collaborative work group has developed a document in response to the proposed rule entitled "Patient Protection and Affordable Care Act; Standard Related to Essential Health Benefits, Actuarial Value and Accreditation" to be distributed to state and federal stakeholders responsible for determining essential health benefit policies. The completed letter provides a collective patient voice outlining nine principles in four general areas (transparency, clarity, access and evolution) that REAP believes the Essential Health Benefits must address in order to meet patient needs. To download a copy of the letter, click here.
To read the proposed rules that the letter addresses visit the links below:
Essential Health Benefits: http://www.gpo.gov/fdsys/pkg/FR-2012-11-26/pdf/2012-28362.pdf
Health Insurance Market: http://www.gpo.gov/fdsys/pkg/FR-2012-11-26/pdf/2012-28428.pdf
Wellness Program: http://www.gpo.gov/fdsys/pkg/FR-2012-11-26/pdf/2012-28361.pdf
Seattle Genetics, Inc. (Nasdaq: SGEN) announced that ADCETRIS (brentuximab vedotin) has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of mycosis fungoides (MF). MF is the most common type of cutaneous T-cell lymphoma (CTCL). Seattle Genetics and its ADCETRIS collaborator, Millennium: The Takeda Oncology Company, are conducting the ALCANZA trial, a phase III clinical trial of ADCETRIS for patients with CD30-positive relapsed CTCL, including MF. ADCETRIS is not approved for the treatment of CTCL. Click here to read the full press release.
In a recent study the use of novel mechlorethamine gel proved as, and in some cases more, effective than mechlorethamine compounded ointment for treating stage IA to IIA mycosis fungoides. While not yet approved by the FDA, the clinical studies have shown promise. To read more about the study, click here.
The Obama administration moved forward to implement provisions in the health care law that would make it illegal for insurance companies to discriminate against people with pre-existing conditions. The provisions of the Affordable Care Act also would make it easier for consumers to compare health plans and employers to promote and encourage employee wellness. To read the full press release, click here.
CLF CEO Susan Thornton participated in REAP's post-election 2012 Policy Consortium - The Patient’s Prognosis held in Washington, DC on November 14. The day was kicked-off by Nancy Davenport-Ennis, CEO, President and Founder of the National Patient Advocate Foundation. Nancy highlighted the work that needs to be done in the legislative and regulatory arena to put the Patient Protection and Affordable Care Act into practice - a challenge given our post-election partisan Congress and the budgetary cost-cutting facing the Nation. The voice of the patient is critical in making sure appropriate decisions are made as the new healthcare law becomes a reality.
With the Supreme Court’s ruling sustaining the Patient Protection and Affordable Care Act, States are tasked with providing Health Insurance Exhanges by 2014 and have an option to expand Medicaid enrollment to millions of uninsured Americans. Patient advocates are looking to the States to determine how access to health services for those with chronic, debilitating and life-threatening conditions will fare during fiscally difficult times and political discord. The event sessions reviewed how different States are planning to support this new initiative.
While there are still many unanswered questions and much remains to be determined during this current “lame duck” session, it was a promising to see representatives from the Senate Finance Committee, David Schwartz, Chief Health Counsel (democrat) and Dan Todd, Health Policy Advisor (republican) demonstrate that within Congress there is a desire to work together over the next month to make the right decisions for the country.
The CLF is a member of the REAP collaborative work group developing nine principles on essential health benefits to be conveyed to state and federal stakeholders responsible for determining essential health benefit policy guidelines. Once the work group has finalized the letter, a copy will be made available on the CLF website.
The CLF recently received the following e-mail from NORD, requesting advocacy action to help prevent the potential loss of research funding. Your voice matters...
You have an opportunity today to do something incredibly important to promote the development of life-saving therapies for people with rare diseases.
Congress has just returned from its post-election recess. Now our nation is in a countdown to devastating budget cuts that will go into effect for NIH, FDA and other government agencies on January 1 if Congress doesn't take action to resolve the budget impasse.
These across-the-board budget cuts of 8.2% would have a major impact on rare disease research funded by NIH and the review of potential new therapies at FDA. They would mean the loss of $2.5 billion from NIH's $30 billion medical research budget. And they could significantly reduce NIH's ability to promote innovation in areas such as translational research to bridge the gap between basic research and treatments for patients.
The cuts would also slice $319 million from FDA's budget and force the agency to undergo major staff reductions, leading to much slower drug reviews and approvals. They would stall implementation of many of the important rare disease provisions in the FDA Safety and Innovation Act that we all worked so hard to get enacted earlier this year.
You can do something to help keep this from happening: In the Legislative Action Center on NORD's website, you'll find a basic letter NORD has prepared that you can personalize with your own information and submit to your members of Congress and the White House. This letter recognizes that our nation is in a fiscal crisis but presents the case for a balanced approach to deficit reduction that does not include further cuts to "Non-Defense Discretionary (NDD) Programs." These are programs representing the core functions that government provides for the benefit of all, including medical and scientific research, education, public health and more.
NORD has joined more than 80 other organizations in the Coalition for Health Funding to present a broad base of support urging Congress and the White House to reach agreement on a deficit reduction plan before January so that the cuts won't be implemented.
Please join us in this important campaign by submitting a letter to your elected officials today urging them not to let "sequestration" (the across-the-board budget cuts) happen. You can personalize your letter by adding information about the way a rare disease has impacted your family. To read and submit letter, click here.
NORD will keep you informed as this situation unfolds. And we encourage you to share this campaign with your family and friends. Our nation is in a fiscal crisis, but cutting medical research programs that create jobs and stimulate our economy is not the answer.
Lundbeck announced that MUSTARGEN (mechlorethamine HCL for injection) is once again available in the United States, effective immediately. Since acquiring MUSTARGEN in 2005, the company has focused on developing a new and secure long-term supply chain for this critical product. Lundbeck worked closely with the U.S. Food and Drug Administration and have invested significant resources to transfer MUSTARGEN production to a state-of-the-art facility that will help enable a consistent, reliable, long-term source of product.
MUSTARGEN, administered intravenously, is indicated for the palliative treatment of Hodgkin's disease (Stages III and IV), lymphosarcoma, chronic myelocytic or chronic lymphocytic leukemia, polycythemia vera, mycosis fungoides, and bronchogenic carcinoma. Mustargen, administered intrapleurally, intraperitoneally, or intrapericardially, is indicated for the palliative treatment of metastatic carcinoma resulting in effusion.
To read the full press release, click here.
Cutaneous Lymphoma Foundation CEO, Susan Thornton recently attended the Cutaneous Lymphoma Task Force for the European Organization for Research & Treatment of Cancer's (EORTC) annual meeting held in Vienna, Austria in early September. This meeting brings together physicians, researchers and specialists in cutaneous lymphoma from across Europe and beyond, including many from the United States. The focus of this year’s meeting was to highlight important new developments in the areas of clinical and basic sciences as well as pathogenesis, diagnosis of and therapy for cutaneous lymphoma.
Over the course of the three-day meeting, 58 presentations were discussed. Topics about the pathology and biology of cutaneous lymphomas covered the histopathology of Sezary syndrome, genomic fingerprint characteristics for mycosis fungoides, methodologies for scoring and staging the disease, possibilities in gene therapy for cutaneous lymphoma along with presentations of current outcomes from clinical trials presently underway around the world, including Dr. Youn Kim’s team at Stanford University and Dr. Elise Olsen from Duke University.
The biggest “aha!” came from the depth of ongoing research being performed in the area of cutaneous lymphoma by these dedicated clinicians. From a patient perspective, it was encouraging to learn about the various efforts around the world dedicated to discovering how cutaneous lymphoma manifests and what can be learned about the specific biomarkers of these cells. This knowledge will allow therapies to be developed that target specific variations of cutaneous lymphoma (mycosis fungoides, Sezary syndrome, follicultropic, cutaneous B-cell, LyP, etc). The research is painstaking and takes patience, but it’s exciting to see the progress that is being made. Everything learned in a research study gives us more information about the disease, how it changes, morphs and how it can be targeted for treatment.
There were also presentations about combining current therapies in different ways to determine overall effectiveness of a new approach. This is leading to new ways of putting together different treatments to get the best response with the least amount of side effects, hopefully in the shortest amount of time. One of the struggles many of the presenters mentioned was the difficulty in getting enough patients to participate in a clinical trial. As you move forward with your treatments, keep an open mind to the option of participating in a trial. These are important steps in determining the best approach to new therapies or a better way of delivering current treatments.
An exciting presentation from the United Kingdom showcased a new iPhone app developed for scoring patients with CTCL. It is based on the severity weighted assessment tool (SWAT) used to assess the body surface as affected by the disease to score patch (T1), plaque (T2) or tumor stages (T3). This new app was presented as a way of creating consistency in scoring methods with a recommendation that future studies be undertaken, potentially using the app, to help scoring consistency across clinicians.
Another area of discussion and presentation was in the area of microRNA expression in cutaneous lymphomas. Cutaneous lymphomas are the most frequent primary skin lymphomas. However, diagnosis of early disease has proven difficult due to a clinical and histological resemblance to benign inflammatory skin disease, like psoriasis, eczema, and others. Many patients can attest to living through this kind of frustration in getting a diagnosis. These various studies are looking to see if microRNA profiling can discriminate cutaneous lymphoma from benign disease like psoriasis which will help in determining a definitive diagnosis earlier and more accurately. There is much more study needed in this area, but knowing that studies are being done to determine ways to diagnose this tricky disease is encouraging. Hopefully in the future, this will help new patients get an earlier and faster diagnosis of cutaneous lymphoma so they can be treated appropriately.
To read more about the presentations, the abstract from the meeting is available by clicking here. Although much of the science is a bit daunting to understand by the lay person, it is exciting to see how much research is actually being done in the area of cutaneous lymphoma.
We will continue to share research information as we learn about it.
microRNA description: From Wikipedia, the free encyclopedia
A microRNA (abbreviated miRNA) is a short ribonucleic acid (RNA) molecule found in eukaryotic cells. A microRNA molecule has very few nucleotides (an average of 22) compared with other RNAs.
miRNAs are post-transcriptional regulators that bind to complementary sequences on target messenger RNA transcripts (mRNAs), usually resulting in translational repression or target degradation and gene silencing. The human genome may encode over 1000 miRNAs, which may target about 60% of mammalian genes and are abundant in many human cell types.
The first miRNAs were characterized in the early 1990s. However, miRNAs were not recognized as a distinct class of biological regulators with conserved functions until the early 2000s. Since then, miRNA research has revealed multiple roles in negative regulation (transcript degradation and sequestering, translational suppression) and possible involvement in positive regulation (transcriptional and translational activation). By affecting gene regulation, miRNAs are likely to be involved in most biological processes.Different sets of expressed miRNAs are found in different cell types and tissues.
Aberrant expression of miRNAs has been implicated in numerous disease states, and miRNA-based therapies are under investigation.
The REAP council - a coalition comprised of 52 of America's leading patient advocacy organizations - met in July to identify, discuss and prepare for upcoming major policy changes that stand to affect health care for patients. Click here to read the full press release.
The National Patient Advocate Foundation recently released a report on how the impact of multiple factors (ie. growing rate of uninsured individuals, aging population, short supply of physicians) will affect a patient's accessibility to care in the very near future. This report is an important reminder on the vital role patient advocacy groups play in keeping health care available and affordable. To read the full report, click here .
Cutaneous Lymphoma Foundation CEO, Susan Thornton, joined over 100 advocates from 15 other national cancer organizations in Washington, DC on July 9-10 as part of One Voice Against Cancer - an important lobbying day for the cancer community.
It is critical for the CLF to participate in these national efforts and contribute the stories of our patients to the 13 million cancer survivors in America today. 1,500 people still die every day of cancer. We added our voice in urging lawmakers to increase funding for federal agencies working towards critical cancer research, prevention programs and drug development.
We asked the legislators to prioritize five initiatives:
-Increase cancer research funding for the National Institutes of Health (NIH) and the National Cancer Institute (NCI).
-Enhance funding for the Centers for Disease Control and Prevention (CDC) for cancer prevention and detection programs and greater support for state and local awareness and education programs.
-Additional funding for the Health Resources and Services Administration's nurse training program to ensure enough resources to boost the nursing workforce.
-Increased funding for the Food and Drug Administration (FDA) to finance critical safety programs, upgrade laboratories, scientific expertise and information technology systems as well as hire more staff to streamline the drug approval process.
-Full appropriation of the $1.25 billion authorized in the Affordable Care Act for Prevention and Public Health Fund as additional support for public health funding.
Although these efforts were not specific to cutaneous lymphoma, all federal and state funding for continued support of cancer research, prevention, education and other support helps us all move forward in the fight against cancer. Participating with other groups like the Lance Armstrong Foundation, American Cancer Society's Cancer Action Network and 40 other organizations as part of the OVAC coalition gives us a stronger voice then we have alone.
You can help too! Write an email or letter to your senators and congressman asking them to support the OVAC initiatives and increase the federal funding for cancer. Adding your personal story and voice to our efforts in Washington will make a difference. Visit these websites to find your congressman or senator.
For 25 years, a therapy called extracorporeal photopheresis (ECP) has been helping patients affected with cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkins lymphoma. By providing patients unresponsive to other therapies with an alternative to pills or topical treatments, this well-tolerated option helps CTCL patients to live their lives, and not be defined by their disease.
Today, as part of a silver anniversary celebration for ECP, Therakos is proud to honor all of the ECP proponents who come together to “light up lives.” Doctors, nurses, technicians and caregivers across the world are part of a tremendous effort to make tomorrow a brighter place for many CTCL patients who have found hope through this pioneering therapy.
This year-long global initiative called Lighting Up Lives aims to raise awareness of ECP and the people whose lives have been positively impacted by this therapy. We hope that your center will join us in this worldwide celebration of ECP by sharing your stories and experiences with ECP as we look to inform the next generation of patients. Together, we hope to continue Lighting Up Lives for the next 25 years and beyond as we look to meet the needs of patients worldwide.
For more information about the celebration and how you can participate, visit the Therakos website www.lightinguplives.com.
Runners in the recent Fourth Annual Music Moves Me Run were cheered on by new Director of Development, Kira Mann representing the Cutaneous Lymphoma Foundation at the Huntsville, Alabama event. The run celebrates the life of Leroy Jefferson Williams, Jr. who passed away from complications of cutaneous T-cell lymphoma in 2008 and is organized by the foundation created in his honor. A portion of the proceeds from the event benefit the Cutaneous Lymphoma Foundation.
Click here to read the full story of Leroy Jefferson Williams, Jr. and and this 5k run.
Millennium: The Takeda Oncology Company and Seattle Genetics, Inc. announce the initiation of an international pivotal phase 3 clinical trial evaluating ADCETRIS in patients with CD30-Expressing Relapsed Cutaneous T-cell Lymphoma.
Click here for full press release.
Ceptaris Therapeutics, Inc., a privately held specialty pharmaceutical company, announced on June 5, 2012 that it has raised $10 million in Series D-1 financing for the operational expenses of producing mechlorethamine gel for the treatment of early stage (stages I-IIA) mycosis fungoides. Ceptaris has also received a Complete Response Letter from the FDA regarding the New Drug Application (NDA) for the gel.
Click here for full press release.
CancerCare has recently made two important changes in it's financial assistance program procedures effective immediately:
CancerCare will no longer accept an application for clients who have not spoken to them first. Prior to transmitting an assistance application, they ask that you please contact a CancerCare oncology social worker via their Hopeline, 800-813-HOPE (4673). The Hopeline is open from 9 a.m. - 7 p.m. EST Monday through Thursday and 9 a.m. - 5 p.m. EST on Friday. Applications will still be viewable from their website, but it will not be possible to download them as they are bar coded for greater efficiency.
Eligibility requirements have been modified to meet an ever increasing demand. Income levels will be set at 250% of the federal poverty limit (FPL). The financial assistance application and instruction will be revised to reflect these changes and will be available on their website for informational purposes only.
Visit the CancerCare website for more information concerning this and other financial assistance programs that they offer.
On March 15, 2012 in San Diego, CA the United States Cutaneous Lymphoma Consortium (USCLC) held its Annual Workshop entitled: CD30+ Lymphoproliferative Disorders (LPD): Controversies and Progress. The recent approval of a novel antibody-drug conjugate that targets CD30, brentuximab vedotin (ADCETRIS, Seattle Genetics), and the recent joint publication of a new set of international clinical practice guidelines for CD30+ LPD by the European Organisation for Research and Treatment of Cancer (EORTC), the International Society for Cutaneous Lymphomas (ISCL) and the USCLC ensured high participation and a very robust, informative discussion.
Click here for a full summary of USCLC Annual Workshop highlights.
Many cutaneous lymphoma patients suffer from itch, which can oftentimes be debilitating and significantly diminish quality of life. That’s why it’s very exciting to see the recent announcement by the National Institutes of Health (NIH) of two major grants that will fund itch research.
As stated by the NIH, this Funding Opportunity Announcement (FOA) will support basic and translational studies aimed at understanding the mechanisms of itch sensation and developing methods to modulate and control itch sensation in disease and rehabilitation. The purpose is to accelerate discovery in this nascent field and to apply new knowledge to improve human conditions relevant to the National Institute of Arthritis & Musculoskeletal and Skin Diseases (NIAMS) mission.
Commenting on this news, Pierluigi Porcu, MD, the Cutaneous Lymphoma Foundation’s Medical Affairs Research Committee Chair and Associate Professor of Internal Medicine, Division of Hematology-Oncology, Ohio State University Comprehensive Cancer Center, had this to share:
“This is an important and timely research funding initiative by the NIH/NIAMS, which should be welcome by all stakeholders in the cutaneous lymphoma community. It is exciting that talent and resources are being invested in the study of a symptom that continues to negatively affect the quality of life of so many of our patients. The fact that this initiative stems from an exploratory roundtable discussion sponsored by NIAMS less than two years ago shows that good ideas can move forward quickly, and that the research community is ready for the task. The FOA covers all the fundamental aspects of the itch problem – from mechanisms and triggers, to neural transmission and perception, all the way to pharmacological modulation and treatment. The FOA specifically encourages a multidisciplinary approach, which aligns perfectly with the vision of the Cutaneous Lymhoma Foundation.”
In a recent article published by the Skin & Allergy News, there’s good news for cutaneous T-cell lymphoma (CTCL) patients suffering from itch. Aprepitant (Emend®) is approved as a drug that is effective in treating nausea and vomiting for cancer patients undergoing chemotherapy. Now there is a growing body of data showing the drug to have a high response in patients with itching resistant to standard treatment including corticosteroids, UV therapy and antihistamines. Recent studies of aprepitant with promising results included patients with mycosis fungoides and Sézary syndrome, two of the most common forms of CTCL.
The 70th Annual Meeting of the American Academy of Dermatology (AAD) was held March 16-20, 2012 in San Diego, CA. Through many activities at the meeting, the Cutaneous Lymphoma Foundation capitalized on opportunities to build awareness, enhance collaborations and strengthen relationships with key partners in its mission.
Click here for a full summary of AAD meeting highlights.
Updated March 8, 2012
A shortage of methotrexate, one of the many systemic agents used to treat patients with cutaneous lymphoma, was recently announced and has been causing some concern. Because for now the shortage is affecting only the IV-administered methotrexate, but not the oral formulation prescribed for cutaneous lymphoma patients, and because effective, alternative therapies are available, the impact on patients with cutaneous lymphoma is believed to be low.
The U.S. Food & Drug Administration (FDA) has completed a prioritized review of, and approved, a preservative-free methotrexate generic drug manufactured by APP Pharmaceuticals. APP's application for preservative-free methotrexate is a supplement to its already-approved generic drug. Following the approval of APP's supplement for methotrexate, the FDA expects that product to become available in March and continue indefinitely.
Click here for the FDA’s website on drug shortages to learn more and keep updated on this shortage.
The Cutaneous Lymphoma Foundation will continue to monitor this situation and provide additional updates when more information is available.
Updated March 8, 2012
In response to the recent critical shortage of Doxil(r) (doxorubicin hydrochloride liposome injection), a systemic therapy used to treat cutaneous lymphoma patients, effective immediately the U.S. Food and Drug Administration is exercising its enforcement discretion for the temporary importation and distribution of Sun Pharma Global's Lipodox(tm) (doxorubicin hydrochloride liposome injection) in the United States by Sun Pharma Global FZE and its authorized distributor, Caraco Pharmaceutical Laboratories Ltd.
The FDA's exercising of regulatory discretion during this critical shortage of Doxil(r) is not expected to eliminate the shortage immediately, but will begin the process of addressing U.S. patient needs. Doxil(r) has been in short supply for several months due to manufacturing issues at an Ohio manufacturing facility. This facility voluntarily closed on November 19, 2011. FDA continues to work with Janssen Research & Development LLC. (the distributor) and Ben Venue Laboratories, Inc. (Janssen's contract manufacturer) to address the short supply.
Click here for the FDA’s website on drug shortages to learn more and keep updated on this shortage.
The Cutaneous Lymphoma Foundation will continue to monitor this situation and provide additional updates when more information is available.
On February 29, 2012, the National Institutes of Health celebrated the fifth annual Rare Disease Day with a day-long celebration and recognition of the various rare diseases research activities supported by the NIH and other organizations. Cutaneous Lymphoma Foundation representatives attended this important event to increase awareness of cutaneous lymphoma, how the disease impacts patients, and advocate for increased rare disease research.
Click here for a full summary of Rare Disease Day highlights.
Representatives from the Cutaneous Lymphoma Foundation attended the 30th Annual Dermatology Nurses’ Association (DNA) Annual Convention on February 16-19, 2012 in Denver, CO with the theme “Taking Dermatology Nursing to New Heights.” Attending educational sessions, heightening visibility of cutaneous lymphoma and the Foundation, and fostering high-impact collaborations with dermatology nurses were among the most important outcomes achieved.
Click here for a full summary of meeting highlights.
Representatives from the Cutaneous Lymphoma Foundation attended the ASH Annual Meeting held in San Diego, CA from December 8 – December 13, 2011. In addition to learning more about the latest in clinical care, therapeutic options and research related to cutaneous T-cell lymphoma (CTCL), Foundation leaders networked with many partners in our mission and celebrated the accomplishments of Dr. Salvia Jain, the recipient of the Foundation’s new Young Investigator Award.
Click here for a full summary of meeting highlights.
Click here to visit our photo gallery where you can view photos from our Young Investigator Award reception.
We have been made aware of Bexarotene (Targretin®) availability issues by Eisai, the drug’s manufacturer. Bexarotene (Targretin®) is available and can be sent overnight to a pharmacy or patient's home for next day delivery. It may be ordered by a pharmacist through these specialty distributors: McKesson Specialty: 877-901-2335 Cardinal Specialty: 866-677-4844 ASD: 800-746-6273
Lundbeck, manufacturer of Mustargen®, the original brand of mechlorethamine, is currently working closely with the U.S. Food and Drug Administration to gain approval of the transfer of production of Mustargen® to a new manufacturing site after the company’s previous contractor discontinued commercial manufacturing of the product. Additional updates on Mustargen® will be provided as they become available.
Currently, compounding pharmacies in the U.S. are using USP mechlorethamine obtained from their wholesale suppliers to compound mechlorethamine ointment for topical use in CTCL.
You should now be able to get your prescriptions filled through your pharmacies. Please instruct the pharmacy to work with their wholesalers to arrange for shipment. If you have any questions about product availability, please contact Valeant’s Customer Care group at 1-800-556-1937. We are pleased that the company was able to work with the FDA to address this drug shortage in a timely manner. Many organizations were involved in advocating for the patients to get this product back on the market.
The International Society for Cutaneous Lymphomas (ISCL) and the cutaneous lymphoma task force of the European Organization of Research and Treatment of Cancer (EORTC) recommends revisions to the Mycosis Fungoides Cooperative Group classification and staging system for cutaneous T-cell lymphoma (CTCL). These revisions are made to incorporate advances related to tumor cell biology and diagnostic techniques as it pertains to mycosis fungoides (MF) and Sezary syndrome (SS) since the 1979 publication of the original guidelines, to clarify certain variables that currently impede effective interinstitution and interinvestigator communication and/or the development of standardized clinical trials in MF and SS, and to provide a platform for tracking other variables of potential prognostic significance. More information about these revisions can be found in a full article in Blood (PDF), a semimonthly publication of the American Society of Hematology.
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