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FDA to Review Spectrum Pharma' Beleodaq

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The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for Spectrum Pharmaceuticals’ (SPPI - Free Report) Beleodaq. Spectrum Pharma is looking to get Beleodaq approved in the U.S. for the treatment of patients suffering from relapsed or refractory peripheral T-cell lymphoma (R/R PTCL).

Spectrum Pharma also mentioned that the FDA will review its application for Beleodaq on a priority basis. A final decision from the U.S. regulatory body on the approval of the candidate is expected by Aug 9, 2014.

The NDA submission was based on positive results from a study on Beleodaq for the above indication. Results revealed an acceptable safety profile and clinical efficacy of the candidate. An overall response rate of 26% was also observed in the heavily pre-treated patient population including patients who had received allogeneic or autologous stem cell transplant.

We are encouraged by Spectrum Pharma’s progress with Beleodaq. Spectrum Pharma gained development and commercialization rights to Beleodaq (North America, India and with an option for China) following a licensing and collaboration agreement with TopoTarget A/S in 2010.

Apart from Beleodaq, Spectrum Pharma also has captisol-enabled melphalan in its pipeline. The candidate is being developed as a conditioning agent for stem cell transplant and multiple myeloma. The company expects to report top-line data from a pivotal study on captisol-enabled melphalan in the second quarter of 2014. Spectrum Pharma intends to file an NDA for the candidate soon after.

Spectrum Pharma currently carries a Zacks Rank #2 (Buy). Some other stocks worth considering include Actelion Ltd. , Biogen Idec Inc. (BIIB - Free Report) and WuXi PharmaTech (Cayman) Inc. . While Actelion and Biogen carry a Zacks Rank #1 (Strong Buy), WuXi Pharma carries a Zacks Rank #2.

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