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Breaking News: Pomalyst® (pomalidomide) Approved by the FDA for Relapsed Myeloma
The FDA today announced approval of Pomalyst® for the treatment of relapsed myeloma.
02.08.13

More great news for myeloma patients. The U.S. Food and Drug Administration today announced approval of Pomalyst® for the treatment of relapsed myeloma. Following the approval of Kyprolis® in August 2012, we now have two new drugs in less than 6 months! The trial results with Pomalyst have been especially positive and encouraging, according to IMF Chairman and Co-founder Brian G.M. Durie, MD. He explains that in the relapsed/refractory setting, about 30% of patients have responded (≥ PR [50% improvement]) and over 60% of patients who have received 1-3 prior therapies had ≥ PR. The length of the responses has been especially promising, reaching approximately 1 year or longer.

"Pomalyst truly fills an unmet need and is a key addition to the arsenal of therapies available to treat myeloma," says Dr. Durie. "The innovation that has led to the availability of new treatments, with several more to come, is really impressive. Congratulations to all who have helped make this possible, from pharma members to investigators, and, of course, the patients who put faith in the possibility of this new drug."

Pomalyst will be available in pharmacies in about two weeks. As is the case with Thalomid and Revlimid, availability will be through the Celgene REMS (Risk Evaluation and Mitigation Strategy) program. Pomalyst will be available by calling 888-423-5436. For information, you can also contact the IMF Hotline: 1-800 452-CURE or hotline@myeloma.org.

Read more about Pomalyst in the IMF press release.

Join an in-depth discussion of Pomalyst and how it will affect treatment options in the future during free teleconference on novel therapies on February 21st at 4:00 PM PST. Register here.

FDA Press Release

Celgene Press Release


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