We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Bristol-Myers' Opdivo/Yervoy sBLA for HCC Gets Priority Review
Read MoreHide Full Article
Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has accepted and granted priority review designation to a supplemental Biologics License Application (sBLA) for the label expansion of Opdivo (nivolumab) in combination with Yervoy. The sBLA is seeking to get the dual immuno-oncology therapy approved in patients with advanced hepatocellular carcinoma (“HCC”), previously treated with Bayer’s (BAYRY - Free Report) chemotherapy, Nexavar (sorafenib). HCC is the most common type of liver cancer. The FDA is expected to give its decision on Mar 10, 2020.
The submission was based on data from the phase I/II CheckMate 040 study investigating Opdivo-Yervoy combo in advanced HCC patients after prior treatment with Nexavar. Data from the study presented at the 2019 American Society of Clinical Oncology ("ASCO") Annual Meeting showed that treatment with Opdivo plus Yervoy yielded objective response rate of 31% and median duration of response of 17.5 months. Meaningful responses were observed across treatment arms.
We note that the FDA also granted Breakthrough Therapy Designation to this dual immuno-oncology therapy for previously-treated advanced HCC patients.
Shares of Bristol-Myers’ shares have increased 11.9% so far this year compared with the industry’s rise of 3.7%.
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 access to a higher patient population and increase its commercial potential significantly.
In a major achievement, Bristol-Myers successfully completed a pivotal study evaluating Opdivo plus low-dose Yervoy in advanced non-small cell lung cancer patients in first-line setting in October. Although Opdivo is approved for treating lung cancer in second or later line setting, the drug is yet to receive approval in first-line lung cancer indication. Lung cancer is the most common form of cancer representing a significant market opportunity. Other immuno-oncology drugs namely Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq have competitive advantage over Opdivo as they are already approved for first-line lung cancer. We expect the success in this pivotal study to change the scenario for Opdivo going forward.
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
Image: Bigstock
Bristol-Myers' Opdivo/Yervoy sBLA for HCC Gets Priority Review
Bristol-Myers Squibb Company (BMY - Free Report) announced that the FDA has accepted and granted priority review designation to a supplemental Biologics License Application (sBLA) for the label expansion of Opdivo (nivolumab) in combination with Yervoy. The sBLA is seeking to get the dual immuno-oncology therapy approved in patients with advanced hepatocellular carcinoma (“HCC”), previously treated with Bayer’s (BAYRY - Free Report) chemotherapy, Nexavar (sorafenib). HCC is the most common type of liver cancer. The FDA is expected to give its decision on Mar 10, 2020.
The submission was based on data from the phase I/II CheckMate 040 study investigating Opdivo-Yervoy combo in advanced HCC patients after prior treatment with Nexavar. Data from the study presented at the 2019 American Society of Clinical Oncology ("ASCO") Annual Meeting showed that treatment with Opdivo plus Yervoy yielded objective response rate of 31% and median duration of response of 17.5 months. Meaningful responses were observed across treatment arms.
We note that the FDA also granted Breakthrough Therapy Designation to this dual immuno-oncology therapy for previously-treated advanced HCC patients.
Shares of Bristol-Myers’ shares have increased 11.9% so far this year compared with the industry’s rise of 3.7%.
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 access to a higher patient population and increase its commercial potential significantly.
In a major achievement, Bristol-Myers successfully completed a pivotal study evaluating Opdivo plus low-dose Yervoy in advanced non-small cell lung cancer patients in first-line setting in October. Although Opdivo is approved for treating lung cancer in second or later line setting, the drug is yet to receive approval in first-line lung cancer indication. Lung cancer is the most common form of cancer representing a significant market opportunity. Other immuno-oncology drugs namely Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq have competitive advantage over Opdivo as they are already approved for first-line lung cancer. We expect the success in this pivotal study to change the scenario for Opdivo going forward.
Bristol-Myers Squibb Company Price
Bristol-Myers Squibb Company price | Bristol-Myers Squibb Company Quote
Zacks Rank
Bristol-Myers currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana.
Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look.
See the pot trades we're targeting>>