Pfizer CEO Ian Read got a little help from the FDA today in highlighting his recent pledge to rely on the late-stage pipeline for future revenue growth. The agency has stamped its approval on dacomitinib, a kinase inhibitor now headed for frontline duty against non-small cell lung cancer.
The drug has a narrowly defined role for cases involving an EGFR exon 19 deletion or exon 21 L858R substitution mutations. It will now be sold as Vizimpro.
Investigators for the company followed a well understood pathway to a quick OK, forging clearly positive progression-free survival data in a trial called ARCHER 1050. The drug arm achieved a PFS of 14.7 months compared to the control arm’s 9.2 months.
The FDA — always ready to move fast when the conditions are right — handed the oncology team at Pfizer a priority review, lopping 4 months off the review schedule and setting the pharma giant on a path to a speedy market launch.
Read recently used dacomitinib as a prime example of a significant late-stage pipeline that has persuaded him to loosen his grip on the company checkbook and start relying more on the internal work at Pfizer rather than partnering and M&A — a longtime strategy which has had mixed results. If Read actually sticks with it, that’s a sea change in the way the company views its role in the global ecosystem.
Not all the KOLs aren’t enthusiastic about its future, though.
2nd gen EGFR TKI dacomitinib was approved by @US_FDA yday for EGFR mut+ NSCLC. In crowded landscape where osimertinib is better tolerated, has longer PFS, & stronger CNS activity, this won't bubble up as a leading choice. #RememberNecitumumab #Yawnhttps://t.co/GvzESqe0py #LCSM
— H. Jack West, MD (@JackWestMD) September 28, 2018
“Pfizer now has two medicines that can tackle three different forms of mutation-driven lung cancer: Xalkori for patients with ALK-positive or ROS1-positive non-small cell lung cancer and Vizimpro for patients with EGFR-mutated non-small cell lung cancer,” said Mace Rothenberg, Pfizer’s chief development officer for oncology.
The tally for novel drug approvals at the FDA now sits at 40, not far behind the record for last year, with a full quarter to break new ground at the FDA.
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