FDA approves Opdivo + Yervoy for HCC previously treated with sorafenib

TAGS

Bristol Myers Squibb has secured approval for the combination of Opdivo (nivolumab) 1 mg/kg and (ipilimumab) 3 mg/kg from the () for the treatment of hepatocellular carcinoma (HCC) in patients who were previously treated with sorafenib.

Approval for the indication has been issued under accelerated approval on the basis of overall response rate and duration of response noted in the Opdivo + Yervoy cohort of the phase 1/2 CheckMate -040 trial.

According to Bristol Myers Squibb, continued approval for the indication in hepatocellular carcinoma could depend upon verification and description of clinical benefit in confirmatory clinical trials.

In the CheckMate -040 cohort of 49 hepatocellular carcinoma patients treated previously with sorafenib, following a minimum follow up of 28 months, 33% of them responded to the Opdivo + Yervoy treatment.  Bristol Myers Squibb said that 8% showed complete response (CR), while 24% had a partial response (PR).

See also  FDA grants EUA for Gilead's investigational COVID-19 drug remdesivir

Duration of responses (DOR) varied from 4.6 to 30.5+ months, with 88% lasting more than six months, 56% at least 12 months and 31% for more than 24 months.

Bristol Myers Squibb gets FDA approval for Opdivo + Yervoy for hepatocellular carcinoma previously treated with sorafenib

Bristol Myers Squibb gets FDA approval for Opdivo + Yervoy for hepatocellular carcinoma previously treated with sorafenib. Photo courtesy of Rept0n1x/Wikipedia.org.

The Opdivo + Yervoy combination is the only dual immunotherapy to get FDA approval in this setting, said  Bristol Myers Squibb. The US pharma company said that the combination therapy has a potentially synergistic mechanism of action that targets two different checkpoints PD-1 and CTLA-4 and works in complementary ways.

See also  Keymed Biosciences breaks new ground with CM518D1 IND approval for hard-to-treat gastrointestinal cancers

The combination was previously given breakthrough therapy designation for the indication and also a priority review from the FDA. It is now approved for the treatment of four forms of cancer.

Adam Lenkowsky – general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb said: “We recognize there is a critical need to provide patients with aggressive forms of cancer, like HCC, new treatment options that may offer clinically meaningful and ultimately durable responses.

See also  Zydus Lifesciences gains FDA approval for Darunavir Tablets in HIV-1 treatment

“Today’s announcement builds on our legacy in pioneering immunotherapy treatments and is an important step in our commitment to transforming patients’ lives through science.”


Discover more from Business-News-Today.com

Subscribe to get the latest posts sent to your email.

CATEGORIES
TAGS
Share This