Regulatory

Riding a wave of positive PhIII readouts, Pfizer gets a snap review for lung cancer drug dacomitinib

Pfizer’s decision to hand over four years of work on a portfolio of off-the-shelf CAR-T drugs doesn’t mean that they’re any less focused on their all-important late-stage oncology pipeline. And the FDA helped make that apparent today by handing the pharma giant a fast-tracked priority review for dacomitinib — one of their top late-stage cancer drugs in line for an initial approval later this year.

Priority review in cancer, which is becoming more of an industry standard these days, cuts four months off the process, giving Pfizer a PDUFA date sometime in September. (Some players like to be coy about the actual date.)

The drug is being aimed at first-line non-small cell lung cancer after the TKI scored a beat over gefitinib, with a median progression-free survival rate of 14.7 months in the head-to-head ARCHER 1050 study compared with 9.2 months in patients treated with gefitinib.

The drug fits in with a pack of cancer drug development efforts at Pfizer, led by a drive to keep Xtandi competitive in prostate cancer while looking for some new hits for Bavencio, a PD/L1 checkpoint inhibitor that’s suffered a couple of setbacks in the clinic. Talazoparib, the PARP inhibitor picked up in the Medivation buyout, hit in Phase III for breast cancer last December, though the data seem to fit in with rivals. In addition, Pfizer is also hustling ahead with lorlatinib for ALK-positive cases — also awarded a priority review in February — and glasdegib, an oral SMO inhibitor initially coded PF-04449913, for acute myeloid leukemia, based on Phase II results.

Pfizer recently spelled out all of its near-term hopes in the clinic, but overlooked a surprising win that was waiting days ago for a long ignored therapy called tafamidis. The Pfizer trial, called ATTR-ACT, tested its drug tafamidis in patients with transthyretin cardiomyopathy, an inherited condition in which proteins don’t fold into their normal shapes correctly. And it is shaping up as a rival to the big blockbuster hope at Alnylam.


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Molecular Templates Jersey City, NJ
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Molecular Templates Austin, TX
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Molecular Templates Jersey City, NJ
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Molecular Templates Austin, TX
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Molecular Templates Austin, TX

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