Biopharmaceutical company Allos Therapeutics, Inc. (ALTH) Friday said U.S. Food and Drug Administration, or FDA, has granted accelerated approval for Folotyn injection as a single agent for the treatment of relapsed or refractory peripheral T-cell lymphoma, or PTCL, an aggressive and rare form of blood cancer with poor prognosis.
Folotyn is granted to use in patients whose cancer has returned or not responded to previous treatment, and there are currently no FDA approved treatments for the disease. Allos said the indication is based on overall response rate. However, the company noted that clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. The company expects to launch the drug in the U.S. in October.
Allos' New Drug Application for Folotyn was based on data from the Propel trial, which is noted to be the largest prospective, multicenter, international trial ever conducted in patients with relapsed or refractory PTCL.
Folotyn's approval was also based on the results from Propel, an open-label, single-arm, multi-center, international clinical trial, in which researchers evaluated 109 patients. The results of the trial demonstrated that 29 of 109 evaluable patients, or 27%, responded to Folotyn.
However, the maximum duration of response was less than 14 weeks, or in a range of 98 to 503 days. The most common grade adverse events were noted to be thrombocytopenia, mucositis, neutropenia, and anemia.
Following the the accelerated approval, Allos has agreed to undertake additional clinical studies to further verify and describe the clinical benefit of Folotyn in patients with T-cell lymphoma.
ALTH is currently trading at $8.22 per share, up 0.86%, on a more than average volume of 1.52 million on the Nasdaq.
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