US Approval for Celgene's Pomalyst - Analyst Blog

The US Food and Drug Administration (FDA) recently delivered encouraging news to Celgene Corporation (CELG) by approving the company’s oncology drug, Pomalyst.

Pomalyst was approved in the US in combination with low-dose dexamethasone for the treatment of relapsed and refractory multiple myeloma (MM) patients, who have received at least 2 prior therapies. Pomalyst has been approved to treat patients whose cancer has worsened on or within 60 days of the last medication.

We remind investors that Celgene had filed a new drug application (NDA) with the FDA seeking approval for Pomalyst last year. The FDA had granted standard review (10 month review period) to the NDA for Pomalyst for the MM indication. The US regulatory body cleared the drug a couple of days before the assigned target date of Feb 10, 2013.

The FDA approval for Pomalyst came on the back of encouraging data from a phase II study (MM-002) on the candidate. Furthermore, in Dec 2012, the company announced encouraging data from the international phase III study (MM-003), which evaluated Pomalyst as a combination therapy in relapsed refractory multiple myeloma patients. The patients did not respond favorably to Takeda’s Velcade and Celgene’s Revlimid, administered either as a monotherapy or in conjunction with other therapy/ies. Data revealed that there was significant improvement in progression-free survival and overall survival in patients in the Pomalyst arm.

The approval of Pomalyst has further boosted Celgene’s already strong oncology product portfolio and should augment its top line as the MM market offers significant commercial potential. We remind investors that the FDA had approved another drug in the MM space last year – Onyx Pharmaceuticals, Inc.’s (ONXX) Kyprolis.

Celgene, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma stocks, such as Medivation, Inc. (MDVN) and Targacept, Inc. (TRGT) presently appear to be more attractive. While Medivation carries a Zacks Rank #2 (Buy), Targacept carries a Zacks Rank #1 (Strong Buy).
 

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