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Bristol Myers (BMY) Gets EC Nod Opdivo+Yervoy in Mesothelioma

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Bristol Myers Squibb (BMY - Free Report) announced that the European Commission (“EC”) has approved the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for yet another indication.

The combination has been approved for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (“MPM”).

The EC nod was based on data from the phase III CheckMate-743 study – the first and only positive phase III study evaluating an immunotherapy in first-line MPM. Data from the same showed that the combination of Opdivo and Yervoy demonstrated superior overall survival versus standard-of-care chemotherapy – the primary endpoint.

Per the company, the combo of Opdivo plus Yervoy is the first new treatment option in more than 15 years to demonstrate improved survival and to be authorized for patients with mesothelioma.

Notably, the approval by the EC was expected, as in April 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of Opdivo plus Yervoy for the first-line treatment of adults with unresectable MPM.

Shares of Bristol Myers have rallied 4.3% so far this year against the industry’s decrease of 4.8%.

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The combination of Opdivo plus Yervoy was approved in October 2020 by the FDA for the first-line treatment of adult patients with unresectable MPM.

Mesothelioma is a rare form of cancer that affects the lining of the lungs with generally poor prognosis. Hence, the approval of the combination should help address an unmet medical need for patients with MPM.

Notably, Opdivo is approved in several countries for various indications — unresectable or metastatic melanoma, metastatic non-small-cell lung carcinoma (“NSCLC”) with progression on or after platinum-based chemotherapy, metastatic small cell lung cancer with progression after platinum-based chemotherapy, advanced renal cell carcinoma (“RCC”), adult patients with classical Hodgkin lymphoma (cHL), and recurrent or metastatic squamous cell carcinoma of the head and the neck, among others.

It is also approved for various indications in combination with Yervoy, like metastatic melanoma, NSCLC, MPM and RCC, among others. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents.

Approval of additional indications should boost Opdivo sales, which were not impressive in the first quarter of 2021. Notably, the drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq.

Zacks Rank & Key Pick

Bristol Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Repligen Corporation (RGEN - Free Report) , which sports a Zacks Rank #2 (Buy) at present. You can see  the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Repligen’s earnings estimates have been revised 15.7% upward for 2021 and 13.4% upward for 2022 over the past 60 days.

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