Bristol-Myers Squibb Company (BMY - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion for the Odpivo plus low-dose Yervoy combination for yet another indication.
The committee recommended approval of the combination for the first-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC).
The recommendation will be reviewed by the European Commission (EC).
The recommendation was based on positive data from the phase III trial, CheckMate -214. We remind investors that the trial was stopped half way following a planned interim analysis, wherein the combination of Opdivo 3 mg/kg plus Yervoy 1 mg/kg demonstrated a significant increase in overall survival (OS) with a 37% decreased risk of death in intermediate- and poor-risk patients, regardless of PD-L1 expression level, compared to a current standard of care, Sutent.
An approval in Europe for RCC will further boost sales.
Bristol-Myers’ stock has decreased 10.8%, against the industry’s growth of 10.5%.
Opdivo is already approved in the United States for RCC.
Opdivo is approved for several indications in the United States and Europe. It became the first PD-1 inhibitor to be approved for a hematological malignancy — classical Hodgkin lymphoma. Opdivo obtained FDA approval for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (“SCCHN”) with disease progression on or after platinum-based therapy.
The European Commission (“EC”) also approved Opdivo as a monotherapy for the treatment of SCCHN in adults progressing on or after platinum-based therapy in April 2017. The drug has been performing impressively, owing to demand resulting from the rapid commercial acceptance for several indications, including melanoma, renal cell carcinoma and second-line non-small-cell lung cancer (“NSCLC”).
The FDA also approved the drug for intravenous use in patients with hepatocellular carcinoma (“HCC”) who have been previously treated with Nexavar. In fact, Opdivo has rapidly penetrated the second line HCC market.
However, Opdivo faces stiff competition from Merck’s (MRK - Free Report) anti-PD-1 therapy, Keytruda, which is approved in the first-line lung cancer setting. Also, Roche’s (RHHBY - Free Report) anti-PDL1 immunotherapy, Tecentriq is approved for the treatment of metastatic NSCLC.
Zacks Rank & Other Key Pick
Bristol-Myers currently carries a Zacks Rank #1 (Strong Buy). Another top-ranked stock from the same space is Gilead Sciences, Inc. (GILD - Free Report) , which carries the same rank as Bristol-Myers. You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings per share estimates increased from $6.58 to $6.87 for 2018 over the past 60 days. Estimates for 2019 are also up by 27 cents.
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