Bristol Myers' Opdivo+Yervoy Combo Gets FDA Nod For HCC
Zacks Investment Research | Mar 11, 2020 10:19PM ET
Bristol Myers Squibb Company (NYSE:BMY) announced that Opdivo (nivolumab) 1 mg/kg plus Yervoy (ipilimumab) 3 mg/kg (injections for intravenous use) has been approved by the FDA to treat hepatocellular carcinoma (HCC) in patients who have been previously treated with Bayer’s (OTC:BAYRY) Nexavar (sorafenib).
The approval was granted under accelerated approval based on the results of the CheckMate -040 trial, in which Opdivo + Yervoy showed an overall response rate of 33% in the given patient population.
The continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
HCC is an aggressive form of lung cancer and the incidence of liver cancer is rising in the United States.
The combination of Opdivo and Yervoy was granted Breakthrough Therapy designation for this indication and a Priority Review by the FDA. Opdivo plus Yervoy is the only dual immunotherapy approved by the FDA in this setting.
We note that Opdivo is currently approved in many countries, including the United States, the EU and Japan, for several cancer indications. The company continues to evaluate Opdivo alone or in combination therapies with Yervoy and other anti-cancer agents. The Opdivo and Yervoy combination is already approved for the treatment of patients with unresectable or metastatic melanoma and intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC). The combination is also indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC).
Bristol-Myers’ shares have gained 10.9% in the past year against the Original post
Get The News You Want
Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers.