Bristol-Myers Squibb has longevity and strong data on its side when it comes to staying on top of the ultracompetitive immuno-oncology field. But a convenience edge certainly can’t hurt.
On Tuesday, the company said it had snagged FDA approval for a less-frequent dosing option that requires patients receive the therapy just once every four weeks, as opposed to every two.
The go-ahead, which BMS said in a statement would “provide healthcare professionals the flexibility to customize patient care,” doesn’t apply to all of Opdivo’s indications, but it does apply to the majority of them—including those in the competitive melanoma, second-line lung cancer and bladder cancer fields.
What’s more, another new approval will make infusions shorter when patients do have to come in, no matter which dose they’re taking. The med snagged an OK for 30-minute infusions across all of its approved indications, cutting the previous amount of time required for infusions in half.
The company is hoping the new green lights will help Opdivo stand apart in an increasingly crowded space. Opdivo has been going at it with archrival Keytruda from Merck since it first hit the market as a melanoma treatment, but more recently, Roche’s Tecentriq, AstraZeneca’s Imfinzi and Pfizer and Merck KGaA’s Bavencio have all entered the fray and begun racking up indications.
Now, though, Opdivo is now the only PD-1 inhibitor to boast a four-week dosing option, Bristol said, and don’t expect BMS to stop there. “Dosing schedule updates for an additional approved indication for Opdivo may be submitted to the FDA in the future,” it said in a statement.
Meanwhile, all eyes are on a space where Opdivo doesn’t currently have the lead, and that’s first-line non-small-cell lung cancer. The company notched an early win last month when its Opdivo-Yervoy combo beat chemo at holding off disease progression in patients with a high tumor mutation burden. But it’s forthcoming overall survival results that could make or break Bristol’s approach, and investors are waiting eagerly for those data.