Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

FDA Grants Accelerated Approval to Nivolumab for HCC Previously Treated With Sorafenib

As a condition of accelerated approval, further trials are required to verify the clinical benefit of nivolumab for this indication
04 Oct 2017
Immunotherapy
Gastrointestinal Cancers

On 22 September 2017, the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Co.) for the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.

Approval was based on a 154-patient subgroup of CHECKMATE-040 (NCT 01658878), a multicentre, open-label trial conducted in patients with HCC and Child-Pugh A cirrhosis who progressed on or were intolerant to sorafenib. In addition to including patients without active hepatitis viral infection, the trial enrolled patients with either active HBV (31%) or HCV (21%) but not those with active co-infection with HBV and HCV or with hepatitis D virus infection. Patients received nivolumab 3 mg/kg by intravenous infusion every 2 weeks. The confirmed overall response rate, as assessed by blinded independent central review using RECIST 1.1, was 14.3% (95% CI: 9.2, 20.8), with 3 complete responses and 19 partial responses. Response duration ranged from 3.2 to 38.2+ months; 91% of responders had responses lasting 6 months or longer and 55% had responses lasting 12 months or longer.  

Common adverse reactions occurring in greater than 20% of patients in nivolumab clinical trials include fatigue, rash, musculoskeletal pain, pruritus, diarrhoea, nausea, asthenia, cough, dyspnoea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, and pyrexia. Adverse reactions occurring in patients with HCC in CHECKMATE-040 were similar to those previously reported in product labelling, with the exception of a higher incidence of elevations in transaminases and bilirubin levels. Treatment with nivolumab resulted in treatment-emergent grade 3 or 4 AST in 27 (18%) patients, grade 3 or 4 ALT in 16 (11%) patients, and grade 3 or 4 bilirubin in 11 (7%) of patients. Immune-mediated hepatitis requiring systemic corticosteroids occurred in 8 (5%) patients.

The recommended nivolumab dose for HCC treatment is 240 mg every 2 weeks.

Full dosing information is available here.  

FDA granted priority review to nivolumab for this indication. As a condition of accelerated approval, further trials will be required to verify the clinical benefit of nivolumab for this indication.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

Last update: 04 Oct 2017

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.