As proof of how the FDA’s “new look” — at approvals — is rapidly evolving, I would note at the top that this Opdivo® follow-on indication had an expected PDUFA date of September 1, 2016. Let that sink in, a moment.
Yet FDA has approved it overnight — nearly four months ahead of even that accelerated schedule. Where the benefit is clear, and the potential to prolong quality time, or save lives is evident, it seems the “new” FDA will truly step-lively, to get an approval jacket completed. Of course, in this particular case, Opdivo has already been FDA-vetted in several other cancers, and represents almost no incremental risk profile to the agency, since FDA is well-aware that many oncologists are already using it off-label for cancers (such as cHL) — where it is not yet formally approved.
I would expect that when Q2 2016 results are available in late July 2016, we will see an additional widening of BMS’s sales revenue lead, over Merck’s Keytruda®, across all cancers (see Q1 2016 chart, at right). To be sure, there will be lots of revenue for Kenilworth, but it looks like BMS has cemented its hold on the No. 1 spot. Here’s a bit, from a press release:
. . . .The U.S. Food and Drug Administration has approved Opdivo (nivolumab) for the treatment of patients with classical Hodgkin lymphoma (cHL) who have relapsed or progressed after autologous hematopoietic stem cell transplantation (auto-HSCT) and post-transplantation brentuximab vedotin.
This accelerated approval is based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. This first approval of a PD-1 inhibitor for cHL patients who have relapsed or progressed after auto-HSCT and post-transplantation brentuximab vedotin is based on a combined analysis of data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials. . . .
We are quite encouraged — and offer Kudos here, to all the FDA staffers.
Now it occurs to me — in a small plug for my occasional one-off blog — that while Chagas is not cancer, and even the “New” KaloBios is certainly not BMS, today’s news does make the more general point that if FDA wants an effective Chagas treatment, it might well reach approval very rapidly, given that there exists over 30 years of safe, effective use, in various studies’ data, on the benznidazole candidate drug — in Latin America. Off now, for a sunny, breezy walk in. . . smiling widely.