Articles tagged with: Revlimid
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Natco Pharma Applies To Sell Generic Lenalidomide In The U.S. – The Indian drug company Natco Pharma filed a request with the Food and Drug Administration to market generic lenalidomide before Celgene’s patents on Revlimid (lenalidomide) expire in 2026. Revlimid is approved in the U.S. for the treatment of myelodysplastic syndromes (MDS) as well as multiple myeloma. Investment analysts have speculated that the patent that extends Revlimid’s exclusivity from 2019 to 2026 is being challenged. Despite this application, the sale of generic lenalidomide is not likely for at least several years. Celgene plans to sue Natco for patent infringement, which would automatically result in a 30-month delay of Natco’s application to sell generic lenalidomide in order to settle the lawsuit. For more information, see the Dow Jones article.
New Myelodysplastic Syndromes Center Opens In New York City – NewYork-Presbyterian Hospital and Columbia University Medical Center have created a new myelodysplastic syndromes (MDS) center that will focus on research and treatment. Dr. Azra Raza, an MDS specialist from Columbia University, will head the new center. Research at the center currently includes the investigation of treatments with tolerable side effects for newly diagnosed MDS patients, as well as the use of genetic testing to determine which patients are most likely to respond to treatment. The center’s goals include controlling symptoms, improving quality of life, and improving survival. For more information, see the NewYork-Presbyterian website.
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Revlimid Receives Approval In Japan For Treatment Of Del-5q Myelodysplastic Syndromes – On Friday, Celgene announced that Japan’s Ministry of Health, Labour and Welfare, the agency that is responsible for the regulation of pharmaceuticals and medical devices in Japan, approved Revlimid (lenalidomide) for the treatment of myelodysplastic syndromes (MDS) associated with a deletion 5q chromosomal abnormality. The approval was based on the efficacy and safety demonstrated during several international clinical trials. In the U.S., the approved use of Revlimid also requires that del-5q MDS patients be dependent on red blood cell transfusions. For more information, please see the Celgene press release.
Conference For MDS Patients And Their Families – The MDS Foundation is sponsoring a one-day conference for patients with MDS and their families on September 9 at the Hilton University of Florida Conference Center in Gainsville. Dr. Christopher Cogle, an MDS specialist from Shands Hospital at the University of Florida, will speak about the latest on the diagnosis and treatment of MDS. The event will begin at 9 a.m. and conclude at 2 p.m. It will include breakfast and lunch and is free to attend. Registration is required. For more information or to register, please see the MDS Foundation website.
For a more detailed listing of MDS related events, please check the MDS Beacon Events Calendar.
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The 15th Congress of the European Hematology Association (EHA) was held June 10 to 13 in Barcelona, Spain. Hematologists specializing in medicine and scientific research gathered to share developments in the field of hematology (blood and blood-related diseases).
Due to the broad number of interests and studies, the congress was divided into different sessions over the course of the four days. It included education sessions and workshops, poster sessions, and presentations about the latest hematologic studies and developments.
The congress featured numerous abstracts and presentations relating to myelodysplastic syndromes (MDS).…
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The side effects of Revlimid (lenalidomide) in the treatment of myelodysplastic syndromes (MDS) are manageable and decrease with additional treatment cycles. Researchers working in multiple centers in Israel and throughout Europe presented these findings at the 2010 American Society of Clinical Oncology (ASCO) annual meeting on June 5.
Revlimid is approved for the treatment of lower risk MDS patients with the chromosomal mutation del-5q. This mutation is characterized by a missing ‘q’ arm in chromosome 5. Revlimid can help these patients become transfusion independent.
The researchers conducted a closer analysis…
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Results from several important studies about myelodysplastic syndromes (MDS) were presented at the annual American Society of Clinical Oncology (ASCO) annual meeting June 4 to 8. No MDS sessions were held on the first or last day of the conference. Presentations from June 5 and 6 are summarized below, and presentations from June 7 will be summarized in a later Beacon article.
Saturday, June 5
During a poster session held on Saturday morning, researchers presented 16 MDS studies in the format of posters. Boards throughout the hall were filled with…
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Combination therapy of Revlimid (lenalidomide) and Vidaza (azacitidine) was effective and well tolerated in high-risk myelodysplastic syndromes (MDS) patients, according to a Phase 1 study performed by United States researchers.
Vidaza is approved in the U.S. for all types of MDS patients, generally delays progression of MDS to acute myeloid leukemia, and improves overall survival. Revlimid is typically used to treat certain low- or intermediate-1 risk MDS patients.
The Phase 1 study results represented attempts by researchers to determine the maximum tolerated dose and the tolerability of the combination treatment…
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Telik Announces Phase 1 Study Of Telintra And Revlimid Combination Therapy for Myelodysplastic Syndromes Patients — Telik, Inc. announced the start of a Phase 1 clinical trial to test the safety, tolerability, and maximum tolerable dose of Telintra (ezatiostat hydrochloride) in combination with Revlimid (lenalidomide) for myelodysplastic syndromes (MDS) patients. Thirty low to intermediate-1 risk MDS patients will receive Telintra in increasing doses. The drug has recently shown positive results for MDS patients as a single agent, either orally or by intravenous injection, and continues to be evaluated as a single agent in a separate Phase 2 study. For more information, please see the Telik press release.
Company Developing Sapacitabine For Treatment Of Myelodysplastic Syndromes To Raise Millions In Direct Offerings — Cyclacel Pharmaceuticals, Inc. announced plans on January 21 to raise up to $7.9 million in capital through registered direct offerings to its investors. The company is currently testing sapacitabine for the treatment of myelodysplastic syndromes (MDS), acute myeloid leukemia (AML), and several other cancers. Interim results of an ongoing Phase 2 clinical trial in MDS were presented at the recent American Society of Hematology annual meeting (see related Beacon news). For more information, please see the Cyclacel press release.
Understanding Clinical Trials For Blood Cancers Like Myelodysplastic Syndromes, LLS Web Seminar — The Leukemia and Lymphoma Society (LLS) is sponsoring an online seminar (webinar) titled “Understanding Clinical Trials For Blood Cancers” on Thursday, January 28, from 7 p.m. to 8 p.m. EST. Dr. Karen Yee will explain clinical trials in detail, including how they are organized, safety concerns, and how myelodysplastic syndromes patients can participate. Registration is required. For more information, please visit the LLS Web site.
For a more detailed listing of MDS-related events, please check the MDS Beacon Events Calendar.
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Revlimid (lenalidomide) given at a dose of 10 mg may be the most effective initial dose for the treatment of myelodysplastic syndromes (MDS), according to the results of a Phase 3 study conducted by a team of international researchers. The findings were presented at the 51st Annual American Society of Hematology (ASH) meeting and exposition on December 8.
For MDS, Revlimid is typically used as a treatment for low- or intermediate-1 risk patients, especially those who require red blood cell transfusions and have del-5q. A del-5q mutation is a chromosomal…
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European researchers have found during a Phase 2 study that Revlimid (lenalidomide) produces an improved chromosomal response in High-risk myelodysplastic syndromes (MDS) patients. The results were presented today at the 51st annual American Society of Hematology (ASH) meeting.
Revlimid has already been used with Low- or Intermediate-1 risk MDS subtypes, especially those who require red blood cell transfusions or have del-5q, as it produces a high rate of transfusion independence and improved chromosomal abnormalities.
Patients with del-5q are missing the ‘q’ arm of chromosome 5.
Although the exact mechanism of…
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A new report by Italian researchers suggests that Revlimid (lenalidomide), administered to myelodysplastic syndromes (MDS) patients on alternate days, may offer comparable efficacy to the standard daily dosing regimen, but with reduced side effects and treatment costs.
In MDS, Revlimid is typically used as a treatment for Low- or Intermediate-1 risk patients, especially those who require red blood cell transfusions and have del-5q. A del-5q mutation is a chromosomal abnormality characterized by a missing ‘q’ arm of chromosome 5.
Revlimid is intended to help MDS patients achieve red blood cell transfusion independence, and is…