Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has approved immuno-oncology drug Opdivo for intravenous use for patients with hepatocellular carcinoma (HCC) who have been previously treated with Nexavar.
The approval for this indication was granted under accelerated approval based on tumor response rate and durability of response.
However, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Per estimates, HCC is the most common type of liver cancer and the fastest-growing cause of cancer death in the U.S.
We note that Opdivo became the first PD-1 inhibitor to be approved for a hematological malignancy — classic Hodgkin lymphoma in both the United States (May 2016) and the EU (November 2016). In November 2016, Opdivo gained the FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after platinum-based therapy.
Bristol-Myers’ stock has rallied 10.7% year to date compared with the industry’s 20.0% gain.
Label expansion into additional indications might give the product access to more patients and increase the commercial potential of the drug.
Additionally, the company entered into a collaboration agreement with Seattle Genetics, Inc. (SGEN - Free Report) in June 2017. Per the deal, Bristol-Myers will evaluate the combination of Opdivo and Seattle Genetics’ antibody drug conjugate (ADC)
Adcetris in a phase III trial as a potential treatment option for patients with relapsed/refractory or transplant-ineligible advanced classical Hodgkin lymphoma (HL).
However, Bristol-Myers suffered a setback in January 2017 when it decided not to pursue the accelerated regulatory pathway for the regimen of Opdivo plus Yervoy in first-line lung cancer in the United States based on a review of available data.
Currently, Opdivo is facing competitive challenges in the United States. With the FDA approving Merck & Co.’s (MRK - Free Report) Keytruda, for the first-line treatment of metastatic nonsquamous NSCLC, the company is expected to suffer further loss of market share.
Meanwhile, the FDA put a partial clinical hold on three clinical trials — CA209602 (CheckMate-602), CA209039 (CheckMate-039) and CA204142. The trials are investigating Opdivo-based combinations in patients with relapsed or refractory multiple myeloma. In addition, concerns from AstraZeneca’s (AZN - Free Report) failed study on lung cancer drug Imfinzi loom large on the company’s CheckMate 227 study on Opdivo.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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