FDA’s Pazdur chides biopharma for falling into an I/O rut

Richard Pazdur

As the FDA’s oncology drug czar, Richard Pazdur has become the federal game master of cancer R&D. His early commitment to the agency’s breakthrough drug designation and the swift delivery of repeated accelerated approvals for the most promising treatments has helped disrupt the field with the first wave of immunotherapies.

Now he has some business advice he’d like to give drug developers: Stay focused on the cutting edge, and lose the me-too drugs in the cancer pipeline.

"People should ask themselves ... would we be better off spending those resources into looking at more novel drugs?" Pazdur told Reuters at ASCO. Going after the same objectives with very similar therapies is all “about reduction of risk,” he added.

According to Reuters, Pazdur was citing the tsunami of PD-1 and PD-L1 immunotherapy programs in the wake of Bristol-Myers Squibb’s ($BMY) early domination, Merck’s ($MRK) significant role as number 2 and the new entry of Roche ($RHHBY), first to the market with a PD-L1 drug designed to take the brakes off the immune system and blast a range of cancers from a brand new angle.

As you can imagine, AstraZeneca ($AZN), Pfizer ($PFE)/Merck KGaA, Regeneron ($REGN) and others in the “me-too” category are likely none too happy with being relegated to the also-ran category. 

"We don't look at ourselves as 'latecomers.' We are leading in multiple areas with combination therapies," responded Bahija Jallal, executive vice president at AstraZeneca's MedImmune unit, now looking for the number 4 spot on the checkpoint list.

Pazdur’s attitude toward de-risked cancer drugs is unlikely to slow companies at this stage. Once committed to a strategy, biopharma companies can be notoriously slow to change course. And with a better understanding of the biology, the industry will likely rack up a host of approvals in the coming years, further crowding the field. 

If they can’t make much money on it, though, they’ll be faced with an “I told you so” from the man who helped forge the revolution and wants to help foster even more dramatic change. 

- here's the report from Reuters

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