Articles tagged with: Pomalyst
News»
Looking back at all that has happened in the world of multiple myeloma since January of 2012, it is hard not to be impressed by the many important developments that took place.
There is the obvious fact that, during that time, not one, but two new drugs to treat myeloma were approved by the U.S. Food and Drug Administration (FDA). Prior to 2012, the FDA had not approved a novel anti-myeloma therapy in over six years.
Yet 2012 was meaningful to the myeloma community for reasons beyond the activity at the FDA’s …
News»
The National Comprehensive Cancer Network (NCCN) recently released an updated version of its guidelines for the diagnosis and treatment of multiple myeloma.
The most notable change to the guidelines is the addition of Kyprolis (carfilzomib), in combination with Revlimid (lenalidomide) and dexamethasone (Decadron), as an alternative treatment option for newly diagnosed myeloma patients eligible for a stem cell transplant.
The guidelines also now list Pomalyst (pomalidomide), in combination with dexamethasone, as a preferred salvage treatment for myeloma.
NCCN guidelines are followed closely by physicians and by many U.S. health …
News»
The results of a recent French Phase 2 study investigating two Pomalyst (pomalidomide) dosing schedules have been published.
The response, survival, and safety data from the study are in line with the results of other Pomalyst trials that have been made public over the past year or two.
In particular, the trial results indicate that the combination of Pomalyst plus low-dose dexamethasone is effective in multiple myeloma patients who have relapsed from, or are resistant to treatment with, Revlimid and Velcade.
Based on the data from this study and as …
News»
Now that Pomalyst has been approved in the United States as a treatment for multiple myeloma, the drug is available for physicians in the U.S. to prescribe for their patients.
The broad availability of Pomalyst, however, raises the important question: For what types of myeloma patients are physicians likely to prescribe Pomalyst?
Early this month, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) for the treatment of certain multiple myeloma patients. These patients must have received at least two prior therapies, including Revlimid (lenalidomide) and Velcade (bortezomib), …
News»
On Friday, the U.S. Food and Drug Administration (FDA) approved Pomalyst (pomalidomide) 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. The article is organized similarly to one the Beacon published about Kyprolis (carfilzomib) after it was approved by the FDA last summer.
What exactly did the FDA …
News»
The United States Food and Drug Administration (FDA) has approved pomalidomide, which will be marketed under the brand name Pomalyst, for the treatment of relapsed and refractory multiple myeloma.
Specifically, Pomalyst has been approved for use in patients with multiple myeloma who have received at least two prior therapies including Revlimid (lenalidomide) and Velcade (bortezomib) and have demonstrated disease progression on or within 60 days of completion of the last therapy.
Celgene (NASDAQ:CELG), the company that will market Pomalyst, has told The Beacon that the drug will be …
News»
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 …
