FDA regulators have apparently given accelerated approval to Allos Therapeutics' treatment for peripheral T-cell lymphomas (PTCL), Folotyn (pralatrexate injection) for treatment of relapsed or refractory PTCLs. The drug could be available in the US as soon as October.
Folotyn becomes the first drug FDA-approved to treat PTCLs.
FDA approval comes despite a lack of convincing clinical data that the drug is effective at stopping the spread of PTCL, or that it can even extend survival. At most, Allos has shown in clinical trials that Folotyn can, among some patients, reduce tumor size.
This news shouldn't be greeted by PTCL patients or their caregivers with too much enthusiasm, since the jury should still be considered out on this drug.
Dive Deeper
ClinicalTrials.gov information concerning pralatrexate
Allos press release
Forbes story on FDA approval
