ALTH 快来看这个到底是不是被批准了，首次推出的药
Allos Therapeutics, Inc. (ALTH) announced that the U.S. FDA's Oncologic Drugs Advisory Committee (ODAC) voted 10-4 that the response rate and duration of response observed with FOLOTYN(TM) (pralatrexate) are reasonably likely to predict clinical benefit in patients with relapsed or refractory peripheral T-cell lymphoma (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. 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 (NDA) for FOLOTYN by September 24, 2009. While the FDA generally follows the recommendations of its advisory committees, it is not required to do so.