Whoa, that was a fascinating news release I saw float through my Twitter stream 2 hours ago:
As CNBC's Mike Huckman pointed out, the link appeared Twitter before the press release alert dropped in our inboxes. Nice one, Genentech!
Anyway, after the very negative ODAC hearing last month where only one panel member voted in favour of approval, it seems that OSI and Roche/Genentech have be granted a reprieve and a chance to address any concerns the FDA may have with the data.
Genentech posted the following statement:
"… the U.S. Food and Drug Administration (FDA) has extended the review period for the supplemental New Drug Application (sNDA) for Tarceva® (erlotinib) as a first-line maintenance therapy in advanced non-small cell lung cancer (NSCLC) by an additional 90 days. The extension follows OSI's submission of further data in support of the application. The original Prescription Drug User Fee Act (PDUFA) date was January 18, 2010. The companies now anticipate FDA action on the sNDA by April 18, 2010."
It will be interesting to see what information and requests the FDA mandates as the story unfolds, but basically, I think many of us were surprised a complete response was not issued after the extensive roasting at ODAC. Perhaps there is some meta analysis that will evolve from further subset analysis, time will tell.
Sometimes it's a good to be lucky!