Allos Therapeutics Inc. (ALTH) said Wednesday that the FDA's Advisory Committee recommends accelerated approval of Folotyn for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma.
The FDA Advisory Committee voted 10-4 that the response rate and duration of response observed with Folotyn are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma or PTCL.
PTCL comprises a biologically diverse group of aggressive blood cancers that has a worse prognosis than most other types of lymphoma, including B-cell lymphoma.
The Advisory Committee recommendation was based on results from PROPEL, a pivotal phase 2 international trial that evaluated Folotyn for the treatment of patients with relapsed or refractory PTCL. The PROPEL trial was conducted under an agreement reached with the FDA under its special protocol assessment, or SPA, process.
If approved, Folotyn would be the first drug approved by the FDA for the treatment of relapsed or refractory PTCL.
The FDA is expected to make a decision whether to approve the company's new drug application for Folotyn by September 24.
ALTH last traded on Sep. 1 at $7.86.
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