Sanofi unveils mixed news for Zaltrap cancer drug
PARIS (Reuters) - Sanofi and Regeneron Pharmaceuticals said their Zaltrap drug candidate failed to meet targets in a late-stage study for the treatment of prostate cancer, though U.S. authorities were reviewing it for use in treating colon cancer.
Regeneron had said in December that Sanofi had withdrawn its application for marketing approval for Zaltrap and was planning to resubmit it early this year.
"The study did not meet the pre-specified criterion of improvement in overall survival," Sanofi said, referring to a Phase III study of Zaltrap, also known as aflibercept, in treating prostate cancer.
Sanofi added in a statement on Thursday that the U.S. Food and Drug Administration had granted a priority review to the companies to examine Zaltrap in the treatment of colon cancer. The FDA is due to give a decision by August 4.
Priority review is granted to a drug if preliminary estimates show it has the potential to provide a treatment where no adequate therapy exists or a significant improvement compared with marketed products, Sanofi said.
"Sanofi and Regeneron are committed to the continued development of Zaltrap," Sanofi oncology head Debasish Roychowdhury said in the statement.
(Reporting by Nina Sovich; Editing by James Regan)
- Tweet this
- Share this
- Digg this
- Malaysia Airlines plane missing at sea off Vietnam, presumed crashed
- Hollywood blockbuster 'Noah' faces ban in Arab world
- UPDATE 3-U.S. FDA probes cognitive impact of new cholesterol drugs
- IndiGo plane evacuated after rear wheel catches fire in Nepal
- CORRECTED-UPDATE 4-Malaysia Airlines plane crashes in South China Sea with 239 people aboard - report
When President Bill Clinton announced in 2000 that Craig Venter and Dr. Francis Collins of the National Human Genome Research Institute had succeeded in mapping the human genome, he solemnly declared that the discovery would "revolutionize" the treatment of virtually all human disease. Full Article