Poniard Pharmaceuticals Receives FDA Fast Track Designation for Picoplatin for Treatment of Small Cell Lung Cancer
Poniard Pharmaceuticals, Inc. , a biopharmaceutical company focused on oncology, today announced that it has been granted fast track designation by the U.S. Food and Drug Administration (FDA) for its lead product candidate, picoplatin, for the second-line treatment of refractory or resistant small cell lung cancer (SCLC). Picoplatin is currently being studied in the pivotal Phase 3 SPEAR (Study of Picoplatin Efficacy After Relapse) trial in SCLC, which is evaluating overall survival as the primary endpoint and is being conducted under a Special Protocol Assessment (SPA) agreement with the FDA.
This entry was posted on Wednesday, September 5th, 2007 at 9:57 am and is filed under Research, Small-Cell. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.