The U.S. Food and Drug Administration (FDA) accepted the New
Drug Application (NDA) for
) 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).
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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
Spectrum Pharma currently carries a Zacks Rank #2 (Buy). Some
other stocks worth considering include
Biogen Idec Inc.
WuXi PharmaTech (Cayman) Inc.
). While Actelion and Biogen carry a Zacks Rank #1 (Strong Buy),
WuXi Pharma carries a Zacks Rank #2.