Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Medicines Agency or EMA's Committee for Medicinal Products for Human Use (“CHMP”) has recommended approval of its blockbuster immuno-oncology drug, Opdivo (nivolumab), in combination with chemotherapy for yet another indication.
Opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, has been recommended for approval for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (“GEJ”), or esophageal adenocarcinoma (“EAC”) whose tumors express PD-L1 with a combined positive score ("CPS") of ≥ 5. The opinion will now be reviewed by the European Commission.
The positive CHMP opinion was based on data from the phase III CheckMate -649 study that compared first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) versus treatment with chemotherapy alone.
Data from the same showed that treatment with Opdivo plus chemotherapy led to a statistically significant and clinically meaningful improvement in overall survival and progression-free survival in patients with unresectable advanced/metastatic gastric cancer, GEJ cancer or EAC whose tumors express PD-L1 with a CPS ≥ 5 – the primary endpoint.
Shares of Bristol Myers have lost 1.1% so far this year against the industry’s growth of 0.9%.
In April 2021, the FDA approved Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression status.
Opdivo is already approved in several countries for multiple indications including melanoma, renal cell carcinoma, second-line non-small-cell lung cancer, classical Hodgkin lymphoma, and recurrent or metastatic squamous cell carcinoma of the head and neck.
Bristol Myers continues to evaluate Opdivo alone or in combination therapies with other anti-cancer agents. In the first six months of 2021, Opdivo generated sales worth $3.6 billion, reflecting an increase of 6% year over year. Label expansion of the drug should boost sales further in the days ahead.
However, competition remains stiff in the immune-oncology space from the likes of Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq in key indications.
Zacks Rank & Key Pick
Bristol Myers currently carries a Zacks Rank #3 (Hold). A top-ranked stock in the biotech sector is Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised 17.8% upward for 2021 and 13.8% upward for 2022 over the past 60 days. The stock has surged 35% year to date.
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Bristol-Myers Squibb Company (BMY - Free Report) announced that the European Medicines Agency or EMA's Committee for Medicinal Products for Human Use (“CHMP”) has recommended approval of its blockbuster immuno-oncology drug, Opdivo (nivolumab), in combination with chemotherapy for yet another indication.
Opdivo, in combination with fluoropyrimidine- and platinum-containing chemotherapy, has been recommended for approval for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (“GEJ”), or esophageal adenocarcinoma (“EAC”) whose tumors express PD-L1 with a combined positive score ("CPS") of ≥ 5. The opinion will now be reviewed by the European Commission.
The positive CHMP opinion was based on data from the phase III CheckMate -649 study that compared first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) versus treatment with chemotherapy alone.
Data from the same showed that treatment with Opdivo plus chemotherapy led to a statistically significant and clinically meaningful improvement in overall survival and progression-free survival in patients with unresectable advanced/metastatic gastric cancer, GEJ cancer or EAC whose tumors express PD-L1 with a CPS ≥ 5 – the primary endpoint.
Shares of Bristol Myers have lost 1.1% so far this year against the industry’s growth of 0.9%.
In April 2021, the FDA approved Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression status.
Opdivo is already approved in several countries for multiple indications including melanoma, renal cell carcinoma, second-line non-small-cell lung cancer, classical Hodgkin lymphoma, and recurrent or metastatic squamous cell carcinoma of the head and neck.
Bristol Myers continues to evaluate Opdivo alone or in combination therapies with other anti-cancer agents. In the first six months of 2021, Opdivo generated sales worth $3.6 billion, reflecting an increase of 6% year over year. Label expansion of the drug should boost sales further in the days ahead.
However, competition remains stiff in the immune-oncology space from the likes of Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq in key indications.
Zacks Rank & Key Pick
Bristol Myers currently carries a Zacks Rank #3 (Hold). A top-ranked stock in the biotech sector is Regeneron Pharmaceuticals, Inc. (REGN - Free Report) , which has a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Regeneron’s earnings estimates have been revised 17.8% upward for 2021 and 13.8% upward for 2022 over the past 60 days. The stock has surged 35% year to date.
Buy 5 Stocks BEFORE Election Day
Biden or Trump? Zacks is releasing a FREE Special Report, Profit from the 2024 Presidential Election (no matter who wins).
Since 1950, presidential election years have been strong for the market. This report names 5 timely stocks to ride the wave of electoral excitement.
They include a medical manufacturer that gained +11,000% in the last 15 years… a rental company absolutely crushing its sector… an energy powerhouse planning to grow its already large dividend by 25%... an aerospace and defense standout that just landed a potentially $80 billion contract… and a giant chipmaker building huge plants in the U.S.
Don’t Wait. Download FREE >>
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