GPC biotech submits clinical section of satraplatin NDA
Germany's GPC Biotech AG has submitted the clinical section of an ongoing New Drug Application to the US Food and Drug Administration requesting approval for use of satraplatin in combination with prednisone as second-line chemotherapy for the treatment of hormone-refractory prostate cancer. This follows the firm's submission of the chemistry, manufacturing and controls section to the agency in late 2005.
Satraplatin as a second line chemotherapy in HRPC received fast track designation from the FDA in 2003 (Marketletters passim), which allows the submission of sections of the NDA as they become available in order to expedite the review process.
Bernd Seizinger, the Munich-headquartered firm's chief executive, said: "the second half of 2006 promises to be of seminal importance for GPC Biotech as we expect to have the final data on progression-free survival from our SPARC registrational trial in the fall and complete the NDA filing by the end of the year."
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze