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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has accepted its supplemental biologics license application (sBLA), seeking approval for a further label expansion of immuno-oncology drug, Opdivo (nivolumab).
The company is seeking approval of the drug in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC).
The FDA has granted the application a Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.
The application was based on positive results from the CheckMate -649 study, which showed that first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) led to a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) for patients with unresectable advanced or metastatic gastric cancer, GEJC or EAC whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5, compared to treatment with chemotherapy alone.
Concurrently, the FDA also accepted its sBLA for Opdivo for the treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy (CRT). The FDA granted the application a Priority Review and assigned a PDUFA goal date of May 20, 2021.
Gastric cancer or stomach cancer is the fifth most common cancer and esophageal cancer is the seventh most common cancer.
Potential label expansions of the drug will boost sales.
Earlier in the month, the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for Opdivo as an adjuvant treatment for GEJ cancer in adult patients with residual pathologic disease after neoadjuvant CRT and resection.
Opdivo is approved in several countries for various indications — unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy, advanced renal cell carcinoma (RCC), adult patients with classical Hodgkin lymphoma (cHL), and recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), among others. It is also approved for various indications in combination with Yervoy.
Shares of Bristol-Myers have decreased 1.8% in the past year against the industry’s growth of 13.9%.
Approval of additional indications should boost Opdivo’s sales, which were not impressive in 2020. Notably, the drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq, particularly for the NSCLC indication.
Earnings estimates for Alkermes have increased 4 cents in the past 60 days for 2021.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
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Bristol Myers' (BMY) Opdivo Label Expansion Gets Priority Review
Bristol Myers Squibb (BMY - Free Report) announced that the FDA has accepted its supplemental biologics license application (sBLA), seeking approval for a further label expansion of immuno-oncology drug, Opdivo (nivolumab).
The company is seeking approval of the drug in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or esophageal adenocarcinoma (EAC).
The FDA has granted the application a Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 25, 2021.
The application was based on positive results from the CheckMate -649 study, which showed that first-line treatment with Opdivo plus leucovorin, 5-fluorouracil and oxaliplatin (FOLFOX) or capecitabine and oxaliplatin (CapeOX) led to a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) for patients with unresectable advanced or metastatic gastric cancer, GEJC or EAC whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5, compared to treatment with chemotherapy alone.
Concurrently, the FDA also accepted its sBLA for Opdivo for the treatment of patients with resected esophageal or gastroesophageal junction (GEJ) cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy (CRT). The FDA granted the application a Priority Review and assigned a PDUFA goal date of May 20, 2021.
Gastric cancer or stomach cancer is the fifth most common cancer and esophageal cancer is the seventh most common cancer.
Potential label expansions of the drug will boost sales.
Earlier in the month, the European Medicines Agency (EMA) validated its Marketing Authorization Application (MAA) for Opdivo as an adjuvant treatment for GEJ cancer in adult patients with residual pathologic disease after neoadjuvant CRT and resection.
Opdivo is approved in several countries for various indications — unresectable or metastatic melanoma, metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy, advanced renal cell carcinoma (RCC), adult patients with classical Hodgkin lymphoma (cHL), and recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), among others. It is also approved for various indications in combination with Yervoy.
Shares of Bristol-Myers have decreased 1.8% in the past year against the industry’s growth of 13.9%.
Approval of additional indications should boost Opdivo’s sales, which were not impressive in 2020. Notably, the drug faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq, particularly for the NSCLC indication.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech space is Alkermes (ALKS - Free Report) , which sports a Zacks Rank #1 (Strong Buy), presently. You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for Alkermes have increased 4 cents in the past 60 days for 2021.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>