Allos Therapeutics' shares were up 8 percent on the news that the FDA had approved Folotyn for use as a single agent for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). It's the first and only drug approved for PTCL, a form of blood cancer that has a poor prognosis and a high relapse rate. The drug did not improve progression-free survival or overall survival in a Phase III study. The approval is based on patients' overall response rate to Folotyn. In connection with the accelerated approval, Allos will conduct additional clinical studies to further define the clinical benefit of Folotyn. The company says the drug will be available in October.
- see Allos' release
- check out the Reuters report