Company recalls application for hormone-refractory PCa drug

Article

GPC Biotech AG has retracted its new drug application for satraplatin, which was submitted for rapid approval to treat hormone-refractory prostate cancer patients who had experienced unsuccessful previous chemotherapy.

GPC Biotech AG has retracted its new drug application for satraplatin, which was submitted for rapid approval to treat hormone-refractory prostate cancer patients who had experienced unsuccessful previous chemotherapy.

The withdrawal was the result of a vote on July 24, 2007, by the Oncologic Drugs Advisory Committee to FDA that stated FDA should hold off on approval until the final survival analysis of a satraplatin trial known as SPARC was completed. SPARC trial results are expected within 5 months.

If the overall survival data from the SPARC trial are positive, GPC Biotech said it would submit a new drug application to the FDA "as quickly as possible."

Related Videos
Daniel J. Heidenberg, MD, answers a question during a Zoom video interview
African American patient explaining issues to Asian doctor using tablet | Image Credit: © rocketclips - stockadobe.com
Todd M. Morgan, MD, answers a question during a Zoom video interview
3D illustration of prostate cancer cells | Image Credit: © Dr_Microbe - stock.adobe.com
Group of doctors reading a document | Image Credit: © Flamingo Images - stock.adobe.com
Brian T. Helfand, MD, and Matthew Smith, MD, PhD, experts on prostate cancer
Related Content
© 2024 MJH Life Sciences

All rights reserved.