Wednesday, May 18, 2016

Immuno-Oncology Races Heat Up: Roche/Genentech Nabs An FDA-Cleared Checkpoint Inhibitor Approval -- Tecentriq®

Well, the immuno-oncology wing of the FDA is popping today. [Of course, there is no formal immuno-oncology wing at FDA -- I just made that up. Smile. it sounds pretty cool though, right?] More seriously, the revamped FDA review process is certainly on full-display, this week. Nicely done, staffers! And it is no exaggeration to call this an emerging three way revolution, in cancer combatting agents -- as of this afternoon. Very gratifying, from a bio-science perspective.

Once again, significantly ahead of earlier time-line expectations, another checkpoint inhibitor immuno-oncology candidate has been green-lighted, by FDA. This new one, called atezolizumab, and branded by Genentech as Tecentriq®, was just approved for a common form of bladder cancers. It is Roche's first entry into this generation of agents -- and while priced on a par with both BMS's Opdivo and Merck's Keytruda -- it is sure to put some heat on Merck, the No. 2 player, in the near term. It is highly foreseeable that some oncologists (with patient consent) will use it off-label, in an experimental fashion, in other cancers. That will likely pressure Merck more than BMS -- as our graphic this morning made plain.

The erstwhile John Carroll (at FierceBiotech) has more of the details, here -- do go read it all:

. . . .The drug will be marketed by Genentech as Tecentriq and sold for $12,500 a month, in parity with rivals Opdivo and Keytruda.

The accelerated OK is based on Phase II data and comes four months ahead of the PDUFA date on the agency’s decision, highlighting once again the FDA’s intense interest in speeding along a new class of cancer drugs that has been making a deep impression on their therapeutic potential.

While Merck and Bristol-Myers made their mark with PD-1 drugs, Roche has been concentrating on PD-L1, a complementary pathway involved in the deceptive game cancer cells play to avoid an immune system attack. And Roche has been paying careful attention in identifying the patients most likely to benefit. . . .

I should also mention that we will expect additional indications, pretty shortly, for the Roche candidate, as well. But this is a high burden cancer, right now. We are now off on foot, in search of soup, on a fine Spring afternoon, awaiting son's arrival by train this evening -- for dinner. . . smile. This is great news for cancer patients. Pax tecum, one and all.

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