Articles tagged with: FDA Approval
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The "what will the FDA decide about pomalidomide" waiting game is reaching its final hours, and the drama is peaking.
Celgene (CELG:NASDAQ), the company that has been developing pomalidomide, asked the U.S. Food and Drug Administration (FDA) last April to approve the drug for the treatment of relapsed and refractory myeloma.
Based on the date the company filed its new drug application with the FDA, the regulator is required to make a decision on the application by this coming Sunday, February 10.
Financial analysts are expecting a positive decision by …
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Last week, the U.S. Food and Drug Administration (FDA) approved Kyprolis (carfilzomib) for the treatment of multiple myeloma patients who have received at least two prior therapies (see related Beacon news).
In this article, The Beacon addresses important questions multiple myeloma patients have been asking about the FDA decision.
What exactly did the FDA approve?
The FDA approved Kyprolis for the treatment of multiple myeloma patients meeting specific criteria. The patients must have received at least two prior therapies. These two therapies must have included Velcade (bortezomib) and an …
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The United States Food and Drug Administration (FDA) has approved carfilzomib, which will be marketed under the brand name Kyprolis, for the treatment of people with multiple myeloma who have received at least two prior therapies.
Specifically, Kyprolis has been approved for myeloma patients who have already been treated with at least Velcade (bortezomib) and either Revlimid (lenalidomide) or thalidomide (Thalomid) and who have also progressed on or within 60 days of completing their last therapy.
“I am very pleased,” said Dr. Vincent Rajkumar from the …
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The United States Food and Drug Administration (FDA) has approved changes to the prescribing information for Velcade (bortezomib), including the addition of long-term data from the VISTA trial showing that Velcade extends survival of newly diagnosed multiple myeloma patients. New dose recommendations for patients with moderate to severe liver damage were also added. The changes were approved in response to a supplemental new drug application (sNDA) submitted by Velcade’s manufacturer, Millennium: The Takeda Oncology Company.
The VISTA trial, titled “Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment with
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FDA Grants Priority Review Status To Velcade – The U.S. Food and Drug Administration (FDA) granted priority review to the supplemental new drug application for Velcade (bortezomib) from Millennium: The Takeda Oncology Company. The supplemental new drug application includes long-term overall survival data from the Phase 3 Vista trial, which examined treatment with Velcade in patients with previously untreated multiple myeloma. Applications granted priority review are approved by the FDA within six months instead of ten. For more information, please see the Millennium press release.
Celgene To Benefit From Increased Use Of Revlimid – Analysts believe that Celgene's stock may recover by the end of this year due to more doctors treating patients with Revlimid (lenalidomide). Revlimid is becoming more accepted as a maintenance treatment for multiple myeloma, lymphoma, and leukemia. Also, Celgene will report on a new clinical trial in December, which may raise sales. For more information, please see the Forbes article.
MMRF Chicago Marathon – On October 11 the Multiple Myeloma Research Foundation (MMRF) team will be taking part in the Bank of America Chicago Marathon. The MMRF is seeking contributions for its runners, which will go towards helping to fund multiple myeloma research. For more information, please visit the MMRF Web site.
For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.
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The U.S. Food and Drug Administration has approved Genzyme’s Mozobil (plerixafor injection), a drug that mobilizes hematopoietic stem cells (HSCs) from the bone marrow into the bloodstream. Mozobil has been approved for non-Hodgkin’s Lymphoma and multiple myeloma.
Mozobil is a small molecule CXCR4 chemokine receptor antagonist. The CXCR4 receptors are responsible for holding HSCs in bone marrow. These stem cells give rise to all blood types and can be used in cancer treatment. CXCR4 antagonists mobilize HSCs in the bloodstream. HSCs are then collected for autologous stem cell transplants, a …