Bristol-Myers' Opdivo nabs European Hodgkin's nod, extending its lead in hematology

Opdivo
Bristol-Myers Squibb's Opdivo won EU approval to treat classical Hodgkin lymphoma patients whose disease has returned after autologous stem cell transplant and treatment with Seattle Genetics’ Adcetris.

Earlier this month, Bristol-Myers Squibb’s Opdivo picked up a new indication in the U.S.—and now, it’s keeping the momentum going with another on the other side of the pond.

On Wednesday, the New Jersey pharma giant announced that European regulators had green-lighted the immuno-oncology powerhouse as a treatment for classical Hodgkin lymphoma (cHL) patients whose disease has returned after autologous stem cell transplant and treatment with Seattle Genetics’ Adcetris.

The nod—which Opdivo already has in the U.S., thanks to a May decision from the FDA—is the first in the EU for a PD-1 inhibitor treating a hematologic malignancy, Bristol-Myers pointed out, meaning it’s a chance for the drug to post a lead on competitors Keytruda from Merck and Tecentriq from Roche. Keytruda and Opdivo have been battling it out since the early days, racing to pick up new indications after their initial advanced melanoma approvals in late 2014. Tecentriq, meanwhile, only recently joined the party with a bladder cancer nod, but it’s pushing hard to catch up to its competitors in other therapeutic areas.

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One such area is lung cancer, where Opdivo is newly vulnerable. After leapfrogging Keytruda to get there first, Opdivo recently surrendered its lead in the space by flubbing a first-line monotherapy trial. And Merck capitalized, winning its own first-line OK shortly thereafter.

Since then, though, Opdivo has come up with a few wins, though they’ve been comparatively small in comparison to the mammoth lung cancer market. Earlier this month, it became the first med in its class to post positive phase 3 results in a gastric cancer study, and that same day, it picked up an FDA approval in head-and-neck cancer, an indication Keytruda already boasts.

As for the Friday win’s potential to boost sales, about 12,200 new cases of Hodgkin lymphoma popped up in the EU in 2012, BMS said, with cHL accounting for 95% of those cases.