Published in Medical Letter on the CDC and FDA, March 21st, 2010
On September 24, 2009, Allos obtained accelerated approval for FOLOTYN™ (pralatrexate injection) from the U.S. Food and Drug Administration (FDA) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This approval was based on overall response rate from our pivotal PROPEL trial. Clinical benefit such as improvement in progression free survival or overall survival has not been demonstrated. FOLOTYN is the first and only drug approved by the FDA for this indication and represents a new treatment...
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