Immuno-oncology, Regulatory

Faster, more convenient Opdivo dosing schedules gives Bristol-Myers added edge in battle of the PD-1 blockbusters with Merck

Looking to hold off a relentless assault by Merck on the top slot in the mega-blockbuster battle of the PD-1/L1 checkpoints, Bristol-Myers Squibb $BMY just scored a couple of new advances that will help its star therapy Opdivo retain its heavyweight title in the field.

Johanna Mercier

Bristol-Myers obtained an FDA approval for a once-every-4 weeks dose of the PD-1, with a 480 mg dose replacing two 240 mg doses. And regulators gave their thumbs up to a 30-minute infusion of Opdivo, cutting their old time in half.

That may not look like much at first glance, but greater conveniences for patients and docs get rewarded with US market share. And Bristol-Myers is scrapping for every slice of market share it can get in the battle of the blockbusters. In cancer, infusion centers have remarkable influence over who gets what cancer treatment.

William Blair analyst Matt Phipps also says this new move could give Bristol-Myers a leg up in maintenance and adjuvant settings, according to a report in Reuters. “Cutting the number of infusions in half with the four-week dosing schedule provides meaningful benefit to patients and reduces the burden at infusion centers,” said Phipps.

Opdivo is approved for a long list of cancers, at various stages of the disease. And the big biotech is pressing hard to add to the roster of approvals.

Opdivo earned close to $5 billion last year, a quarter of the company’s revenue.

Johanna Mercier, head of Bristol-Myers’ US commercial ops, did the honors in touting the move. She said:

With this approval, we now offer the most robust range of dosing options for an immuno-oncology medicine, providing enhanced flexibility to help address each patient’s specific needs.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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