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news.Poniard Pharmaceuticals has been granted Fast Track status by the FDA for its lead product candidate, picoplatin, for the second-line treatment of refractory or resistant small cell lung cancer.
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Picoplatin is currently being studied in the pivotal Phase III SPEAR (study of picoplatin efficacy after relapse) trial in small cell lung cancer (SCLC), which is evaluating overall survival as the primary endpoint and is being conducted under a special protocol assessment agreement with the FDA.
Poniard’s updated data from its Phase II SCLC trial confirmed and extended a median overall survival of 27 weeks (based on an analysis of 63 patients), which compares favorably to a median survival of approximately 17 to 22 weeks for patients who receive other second-line chemotherapy, according to the 2007 national comprehensive cancer network practice guidelines.
“Our receipt of Fast Track designation has the potential to accelerate the development of picoplatin for the treatment of small cell lung cancer, a difficult-to-treat disease, and a patient population with very limited treatment options,” said Jerry McMahon, chairman and CEO of Poniard.
“We are focused on executing our ongoing Phase III SPEAR trial to facilitate the expeditious filing of a new drug application and obtaining the approvals required to make picoplatin available to this severely underserved patient population.”