Allos off as CHMP recommends against approval of Folotyn
Allos Therapeutics Inc. (NASDAQ:ALTH) was off $0.15 to $1.51 on Friday after EMA's CHMP recommended against conditional approval of Folotyn pralatrexate to treat relapsed or refractory peripheral T cell lymphoma. The MAA was based on data from the pivotal, single-arm Phase II PROPEL trial, which evaluated a primary endpoint of objective response rate. CHMP said it could not assess Folotyn's benefit because it was not compared against placebo or any other treatment. The committee added that the trial did not allow it to assess Folotyn's effect on overall survival (OS) or progression-free survival (PFS). Allos, which believes the data meet the criteria for conditional approval, plans to submit a request for reexamination within two weeks. Allos is co-developing the small molecule dihydrofolate reductase (DHFR) inhibitor with Mundipharma International Ltd. (Cambridge, U.K.), which has exclusive rights to commercialize the product outside the U.S. and Canada. ...