Bristol-Myers' Opdivo wins EU nod in lymphoma
- Bristol-Myer's Squibb's Opdivo (nivolumab) won European approval for treatment of relapsed/refractory classical Hodgkin lymphoma (cHL), making the blockbuster drug the first PD-1/PD-L1 inhibitor okayed in the EU for a hematological malignancy, the drugmaker said Tuesday.
- Opdivo can now be used to treat cHL after autologous stem cell transplant (ASCT) and treatment with Seattle Genetics' Adcetris (brentuximab vedotin).
- The EU gave Opdivo a green light based on data from the Phase 2 CheckMate-205 and Phase 1 CheckMate-039 studies, which showed an objective response rate of 66% and progression-free survival of 57% at 12 months.
This approval is Opdivo's sixth EU approval, ranging across four cancer types. The drug has now scored approvals in cHL, advanced unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) and in advanced renal cell carcinoma.
Another application for approval, in advanced head and neck cancer, is still pending.
Opdivo has racked up approvals around the world, both as a monotherapy and in combination with Bristol-Myers' other immunotherapy Yervoy (ipilimumab). Sales of the drug have quickly lapped those of Merck's rival Keytruda (pembrolizumab), propelling Bristol-Myers' revenues sharply higher.
Yet a major trial setback in first-line NSCLC in the U.S. earlier this year may have opened the door for Keytruda to catch up. Keytruda won approval in that indication late last month and should soon see a sizable bump from being able to market to that wider population.
Opdivo will still likely maintain an overall sales edge over Keytruda for some time, though, helped in part by the wider array of approvals across geographies.
Pricing is one area to watch moving forward. As Keytruda continues to make gains and Roche's Tecentriq inches into the market, competition between the three may put some pressure on the pricey drugs.
Opdivo faced a challenge in Japan this week, for example. According to The Japan Times, the Japanese government has halved the official price of the drug as an emergency cost-cutting measure. And the U.K.'s National Institute for Health and Care Excellence, a cost watchdog, recently refused to recommend coverage for the drug due to cost.
- Bristol-Myers Squibb Statement
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