Today, the Oncology Drug Advisory Board to the FDA recommended approval for the drug pralatrexate, a treatment for patients with relapsed or refractory peripheral T-Cell lymphoma. Following a 10-4 vote in favor of approval the FDA will make the final decision on approval September 24th.
Pralatrexate was discovered at Memorial Sloan Cancer Center in New York and later in-licensed by Allos in 2002 during my tenure as CEO. In those early years we could barely scrape enough money together to keep the development programs going, but we managed. We had several spirited discussions at board meetings about terminating the program; some so spirited, in fact, that they undoubtedly contributed to my ouster in early 2006. But we persevered, all believing that one day pralatrexate could be approved.
Today’s recommendation by ODAC does not constitute approval, but it does represent a significant milestone on the path to approval.
Congratulations to the team at Allos Therapeutics and to all those who came before you and to those that fought to develop pralatrexate along the way.
UPDATE: On September 25, 2009 the FDA approved pralatrexate, trade name Folotyn, as the first and only approved therapy for relapsed or refractory peripheral T-Cell lymphoma.