Bristol-Myers' Drug Combination Gets EU Nod for Renal Cancer
Bristol-Myers Squibb Company BMY announced that the European Commission approved the immuno-oncology combination of Opdivo and low-dose Yervoy for the first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC), the most common type of kidney cancer.
The approval was supported by results from the phase III CheckMate-214 study, which stopped following a planned interim analysis. The planned interim analysis showed that the combination of Opdivo (3 mg/kg ) plus low-dose Yervoy (1 mg/kg) demonstrated a significant increase in overall survival (OS), with 37% decreased risk of death in intermediate- and poor-risk patients compared to a current standard of care, Pfizer’s PFE Sutent (sunitinib).
The combination of Opdivo plus Yervoy in first-line RCC was approved in the United States in April last year. The combination is now approved for three types of tumors — renal, colorectal and melanoma. This should boost sales further, given the market potential.
Bristol-Myers’ shares have declined 13.7% in the past year, against the industry’s growth of 5.1%.
We note that Opdivo became the first PD-1 immune checkpoint inhibitor to gain regulatory approval in July 2014. It is currently approved in several countries, including the United States, the EU and Japan, for several cancer indications.
Meanwhile, the company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. Label expansion of the drug into additional indications would give the product an access to a higher patient population and increase its commercial potential significantly.
We remind investors that Bristol-Myers has offered $74 billion in cash and stock to acquire another cancer giant Celgene CELG. The acquisition will enable Bristol-Myers to diversify its portfolio. The combined company will have a dominant position in the oncology, immunology and inflammation spaces.
In another big deal, Lilly LLY offered to take over Loxo Oncology for $8 billion to expand its oncology portfolio into precision medicines or targeted therapies.
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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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