Articles tagged with: Immunomodulatory Agents
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Boudry, Switzerland (Press Release) – Celgene International Sàrl, a wholly owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for continuous oral treatment with REVLIMID® in adult patients with previously untreated multiple myeloma who are not eligible for stem cell transplantation.
The CHMP reviews applications for all 28 member states in the European Union (EU), as well as Norway, Liechtenstein and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately …
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POMALYST Is A New Option For Patients Whose Disease Has Progressed Despite Treatment With Available Therapies
Mississauga, Ontario (Press Release) - Health Canada has approved POMALYST™ oral therapy (pomalidomide capsules) in combination with dexamethasone, for patients with multiple myeloma for whom both lenalidomide and bortezomib have failed, who have received at least two prior treatment regimens and have demonstrated disease progression on their last regimen. Until POMALYST, there have been few options for patients whose disease has progressed despite being treated with traditional therapies. Treatment with POMALYST has been shown to improve rates of overall survival and extend progression-free survival in patients who no longer respond to lenalidomide …
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Boston (Press Release) - Despite its tragic legacy of causing birth defects 50 years ago, thalidomide – and newer drugs derived from it – has been reborn as an effective treatment for multiple myeloma and other cancers. How they act to slow cancer's spread, however, has long defied explanation.
In a new report, scientists at Dana-Farber Cancer Institute say they have discovered that the drugs kill multiple myeloma cells by a mechanism that's different from the way that they cause birth defects.
As a result, "It may be possible to develop better …
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Study is one of more than 160 abstracts evaluating 10 Celgene compounds across a range of blood cancers
Boudry, Switzerland (Press Release) - Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG) today announced that data from FIRST® (Frontline Investigation of Lenalidomide + Dexamethasone Versus Standard Thalidomide), its phase III study (MM-020/IFM 07-01) of REVLIMID® (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma (NDMM) ineligible for stem cell transplant will be presented on Sunday, Dec. 8 during the plenary session of the 55thAmerican Society of Hematology annual meeting in New Orleans, La.
Abstracts for the meeting were released today on the society’s …
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Pomalidomide plus low-dose dexamethasone demonstrated significantly longer median progression-free survival and overall survival at a median follow-up of 10 months
Boudry, Switzerland (Press Release) - Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ:CELG), today announced that updated results from MM-003, a phase III multi-center, randomized open-label study (n=455) of pomalidomide (marketed as POMALYST® in the U.S. and IMNOVID® in the E.U.) plus low-dose dexamethasone, were published online ahead of print in The Lancet Oncology.
The study compared oral pomalidomide plus low-dose dexamethasone with high-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma who have failed at least two prior therapies with both bortezomib and lenalidomide, administered alone or in …
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Boudry, Switzerland (Press Release) - Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that the European Commission (EC) has granted approval for Pomalidomide Celgene® (pomalidomide), in combination with dexamethasone, for the treatment of relapsed and refractory multiple myeloma (rrMM) in adult patients who have received at least two prior therapies including both lenalidomide and bortezomib and have demonstrated disease progression on the last therapy.1 Celgene intends to launch Pomalidomide Celgene in the EU under the trade name “IMNOVID®”, following submission of a regulatory notification to the European Medicines …
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Boudry, Switzerland (Press Release) - Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that data evaluating treatment with REVLIMID® (lenalidomide) in combination with dexamethasone followed by REVLIMID maintenance therapy in patients with high-risk asymptomatic smoldering multiple myeloma were published in the August 1 edition of The New England Journal of Medicine. Smoldering multiple myeloma is an early, asymptomatic form of the disease characterized by a 10% per year risk of progression to symptomatic disease over the first five years.
The Phase III, randomized, multicenter, open-label study, led by Maria-Victoria Mateos, …