Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rendered a positive opinion recommending the approval of a four-week dosing schedule for its high-profile immuno-oncology drug Opdivo (nivolumab) as an adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease having undergone complete resection.
The committee has recommended the approval for flexible dosing options of a flat dosing schedule of Opdivo 240 mg infused over 30 minutes every two weeks or 480 mg infused over 60 minutes every four weeks for the above-mentioned patient population.
Shares of Bristol-Myers have lost 3.8% so far this year against the industry’s increase of 0.1%.
We remind investors that Opdivo is Bristol-Myers' primary growth driver. It is currently approved in the United States, the EU, Japan and other countries for several cancer indications. The blockbuster drug generated sales of $3.6 billion in the first half of 2019, reflecting a rise of 15% year over year. The company is further working on expanding the drug's label.
Earlier this month, Bristol-Myers announced long-term pooled efficacy and safety results from the phase III CheckMate-017 and CheckMate-057 studies on Opdivo in patients with previously-treated, advanced non-small cell lung cancer (NSCLC).
The outcomes showed that at five years, patients treated with Opdivo continued to experience long-term overall survival (OS) benefit compared to docetaxel. Treatment with Opdivo was associated with a 5-year OS rate of 13.4% compared to 2.6% with docetaxel in previously-treated NSCLC patients.
However, competition is stiff in the NSCLC market. Opdivo faces severe rivalry from Merck's (MRK - Free Report) PD-L1 inhibitor Keytruda, which commands a strong place in the first-line NSCLC market. Other PD-L1 inhibitors available in the same space are AstraZeneca's (AZN - Free Report) Imfinzi and Roche's (RHHBY - Free Report) Tecentriq.
Opdivo's label expansion into additional indications would give the product access to a higher patient population and increase its commercial potential significantly.
Bristol-Myers currently has 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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