Quoting sources, Reuters reports that Roche's remarkable experimental melanoma drug vemurafenib appears headed for an early approval by the FDA.
Roche filed for an approval in May, putting it in line for a final decision by October 28. But encouraged by some dramatic evidence that the drug significantly cut the risk of death versus chemotherapy, the news service's source says that an approval may be just around the corner.
"We are getting the sense that approval is imminent," the source told Reuters.
Vemurafenib, which will be named Zelboraf on the market, is likely to join a roster of new cancer drugs to gain FDA approval. The agency approved Bristol-Myers Squibb's melanoma drug Yervoy last March with an approval for J&J's prostate cancer therapy Zytiga arriving just weeks later. Peak sales of vemurafenib have been estimated at more than $700 million a year.
Roche's vemurafenib was advanced by Plexxikon, a biotech that was bought out last March by Daiichi Sankyo in a $935 million deal. The drug took center stage at ASCO last June as a poster child of sorts for drugs developed to target the molecular drivers of cancer growth.
- here's the report from Reuters