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Bristol Myers (BMY) Skin Cancer Drug Gets EC's Approval

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Bristol Myers Squibb (BMY - Free Report) recently announced that the European Commission (“EC”) has approved Opdualag for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumor cell PD-L1 expression <1%.

Opdualag is a first-in-class, fixed-dose dual immunotherapy combination treatment of the PD-1 inhibitor Opdivo (nivolumab) and novel LAG-3-blocking antibody relatlimab.

The EC’s decision is based upon an exploratory analysis of results from the phase II/III RELATIVITY-047 study in patients with tumor cell expression <1%, which demonstrated that treatment with the fixed-dose combination of the PD-1 inhibitor nivolumab and novel LAG-3-blocking antibody relatlimab more than doubled the median progression-free survival (PFS) compared to nivolumab monotherapy – an established standard of care. Data did not show any safety events with the combination when compared to nivolumab monotherapy. The RELATIVITY-047 trial also met its primary endpoint of PFS in the all-comer population.

The drug is also approved in the United States for treating adult and pediatric patients 12 years of age or older for the same indication.

Shares of Bristol Myers have gained 14.7% in the year so far against the industry’s decline of 23.6%.


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The approval of potential new drugs and the label expansion of existing drugs will add an incremental revenue stream to boost growth in the coming quarters as one of Bristol Myers’ top drugs, Revlimid, is now facing generic competition, which is affecting the top line and will erode sales rapidly.

Camzyos (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) was approved in the United States for treating adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM) to improve functional capacity and symptoms.

However, results from the mid-stage AXIOMATIC-SSP dose-ranging study of experimental candidate milvexian, announced last month, were disappointing. The candidate is being developed to prevent new symptomatic ischemic stroke or new covert brain infarction in patients receiving aspirin and clopidogrel following an acute ischemic stroke or transient ischemic attack.

Competition is also stiff for Opdivo, one of the top drugs of Bristol Myers, from the likes of Merck’s (MRK - Free Report) Keytruda. The drug, approved for various oncology indications, is the key driver for Merck.

Bristol Myers currently carries a Zacks Rank #3 (Hold).  A couple of better-ranked stocks in the sector are Bolt Pharmaceuticals (BOLT - Free Report) and Dynavax (DVAX - Free Report) , both presently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Loss estimates for BOLT have narrowed to $2.25 from $2.87 in the past 60 days. BOLT surpassed on earnings in three of the trailing four quarters and missed on the same in the remaining one, the average beat being 2.39%.

Dynavax’s earnings estimates have increased to $1.73 from $1.14 for 2022 over the past 60 days. Earnings of DVAX surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average beat being 70.57%.


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