Reuters has the "exclusive" this morning that the FDA may approve Merck's PD-1 immuno-oncology superstar pembrolizumab for melanoma some weeks ahead of the Oct. 28 PDUFA date. Then again, they may not, but it's looking good, according to the wire service.
That wouldn't be a big surprise to many longtime observers. The agency's cancer division under Richard Pazdur has already tapped this program as a potential "breakthrough" warranting speedy action. And Pazdur clearly loves nothing more than zipping something like this right along, so shaving a few weeks off the process would be completely in line with my own expectations.
The agency has a chance to pat itself on the back, Merck ($MRK) joins in and there are high fives all around.
An early approval, though, would also highlight a big trend in cancer drug development. Merck went from a big Phase I straight into registration studies with this drug. And in doing so they have helped transform the way the industry approaches clinical stage timelines in oncology, cutting out months and even years out of the process. That's a theme that will have a big impact on the full lineup of cancer drugs now stuffing the pipeline; just don't expect it to spill over suddenly into other areas like diabetes and neurosciences.
For Merck, a quicker snap from the agency also puts the company right where it needs to be: First in line with a pioneering approval for a new class of drugs that could prove to be a mammoth in the marketplace. Pembrolizumab (MK-3475), along with other advances under R&D chief Roger Perlmutter, has made it possible for the division to switch its focus on reorganization and downsizing to growth and new opportunities. So a reinvigorated Merck is likely to do more deals and hustle along new drugs, helping salvage one of the industry's great research organizations after years of muddling along.
That by itself is huge, as my kids like to say. -- John Carroll (email | Twitter)