Bristol Myers Squibb Company 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 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).