Marine-Based Drugs Face Choppy Waters, But 13 Compounds In Clinical Trials
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
When an FDA advisory committee voted against approval of Yondelis (trabectedin) for treatment of relapsed ovarian cancer, drug sponsor Centocor/Ortho Biotech wasn't the only one that was disappointed. Researchers focused on marine natural products have been tracking Yondelis, one of the leading sea-based compounds, and its clearance in the U.S. would have been a boon for their field.
You may also be interested in...
ODAC Says Toxicity Trumps Meager PFS And TTP Benefit for Yondelis, Doxil
Changing endpoints midway through the clinical trials for the two Centocor/Ortho Biotech oncology drugs reviewed by FDA's Oncologic Drugs Advisory Committee July 15 did not help their regulatory prospects - but in the end it was the poor efficacy and unacceptable toxicity that doomed both Yondelis and Doxil
Overly Aggressive Prialt Dose Data Are Not Surrogate Endpoints, FDA Says
Data from failed dosing protocols do not constitute surrogate endpoints, FDA informed Elan in rejecting the company’s bid for accelerated approval of Prialt.
FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011
Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011