Yesterday, the US Food and Drug Administration’s (FDA) panel came out with a favorable recommendation regarding the approval of Allos Therapeutics’ (ALTH) lymphoma drug Folotyn (pralatrexate). The company is seeking approval of Folotyn for the treatment of relapsed or refractory peripheral T-Cell lymphoma (PTCL). Although the FDA is not required to follow the panel’s advice, it generally does so. The agency is supposed to take a final decision on the drug by Sept 24.
The FDA panel voted 10-4 in favor of the drug along with stating that new treatments are required for the disease. Studies conducted by the company did not record robust data. The number of patients who responded to the treatment was quite less (27% of 115 patients) with majority of them responding only partially. Benefit of the treatment lasted for less than 14 weeks for more than half of the responding patients. The panel voted in favor of the drug in spite of not very impressive clinical data due to the current unmet medical need of these patients.
Currently, there is no FDA approved drug for T-Cell lymphoma (which attacks the immune system). According to the FDA, though PTCL is a less common type of non-Hodgkin’s lymphoma, about 9,500 people in the US are affected by it. Apart from T-cell lymphoma, the drug is being studied for several other indications including non-small cell lung cancer (NSCLC), bladder cancer, non-Hodgkin’s lymphoma (NHL) and Hodgkin’s disease.
Although we are pleased with the favorable panel recommendation, we remain concerned about the prospects of final approval. FDA approval is quite crucial for Allos as the company is depending heavily on Folotyn and has little to fall back on, should the drug fail to receive FDA approval.
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