The FDA has rejected Centecor Ortho Biotech's application to market Doxil in combination with Zeltia's Yondelis (trabectedin) as a treatment for ovarian cancer. Following a panel recommendation issued in July, the agency said it will need more data on overall survival from a Phase III trial already underway, as well as additional pharmacology studies.
The Johnson & Johnson subsidiary said it will review the agency's questions as quickly as possible. "We have full confidence in the product, and (believe) that Johnson will provide the additional information," a Zeltia spokeswoman told the Wall Street Journal.
The expert panel convened in July rejected the Yondelis-Doxil combo due to the heart and liver toxicity risks and the limited effectiveness of the combination. Clinical data showed that the drug only delayed disease progressin by six weeks--a benefit not worth the added risks, the panel concluded.
- here's the Centecor release