Bristol Myers Squibb BMY introduced that the European Fee (EC) has permitted its blockbuster immuno-oncology drug, Opdivo (nivolumab), for one more indication.
The drug is now permitted for the remedy of adults with unresectable superior, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) as a second-line remedy. The drug is permitted for this after prior fluoropyrimidine- and platinum-based mixture chemotherapy.
The approval was primarily based on outcomes from the part III ATTRACTION-Three examine, sponsored by Ono Pharmaceutical Co., Ltd. of Japan, which demonstrated a statistically important and clinically significant enchancment in general survival (OS) in sufferers who acquired Opdivo as in comparison with these receiving chemotherapy. The protection profile for Opdivo was favorable in contrast with chemotherapy and in keeping with beforehand reported research of the drug in different strong tumors.
On a worldwide foundation, esophageal most cancers is the seventh most typical most cancers and the sixth most typical reason for loss of life from most cancers.
We word that Opdivo is already permitted in the US and Japan, for the second-line remedy of sufferers with unresectable superior, recurrent or metastatic ESCC. Approval in extra geographies will increase the gross sales potential of the drug.
Opdivo is permitted in a number of nations for varied indications — unresectable or metastatic melanoma, metastatic non-small cell lung most cancers (NSCLC) with development on or after platinum-based chemotherapy, metastatic small cell lung most cancers (SCLC) with development after platinum-based chemotherapy, superior renal cell carcinoma (RCC), grownup sufferers with classical Hodgkin lymphoma (cHL), and recurrent or metastatic squamous cell carcinoma of the top and neck (SCCHN), amongst others. It is usually permitted for varied indications together with Yervoy.
Shares of Bristol-Myers have decreased 1.5% thus far this yr, in-line with the trade’s decline.
Approval of extra indications ought to increase Opdivo’s gross sales, which weren’t spectacular within the yr thus far. Notably, the drug faces stiff competitors from Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq, significantly for the NSCLC indication.
Bristol-Myers at the moment carries a Zacks Rank #3 (Maintain). A greater-ranked stock within the biotech house is Halozyme Therapeutics, Inc. HALO, which sports activities a Zacks Rank #1 (Robust Purchase), presently. You’ll be able to see the entire record of at present’s Zacks #1 Rank stocks right here.
Halozyme’s earnings estimates are up 15 cents for 2020 prior to now 30 days.
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