FDA approves Opdivo and Yervoy for front-line advanced RCC

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA has granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.

The approvals were based on CheckMate 214 (NCT02231749), a randomized open-label trial. Patients with previously untreated advanced RCC received nivolumab (3 mg/kg) plus ipilimumab (1 mg/kg) every 3 weeks for 4 doses followed by nivolumab monotherapy (3 mg/kg) every 2 weeks, or sunitinib 50 mg daily for 4 weeks followed by 2 weeks off every cycle.

Efficacy was evaluated in intermediate or poor-risk patients (n=847). The trial demonstrated statistically significant improvements in overall survival and objective response rate for patients receiving the combination (n=425) compared with those receiving sunitinib (n=422).

Estimated median OS was not estimable in the combination arm compared with 25.9 months in the sunitinib arm (hazard ratio 0.63, 95% CI: 0.44, 0.89; p<0.0001). The ORR was 41.6% (95% CI: 36.9, 46.5) for the combination versus 26.5% (95% CI: 22.4, 31) in the sunitinib arm (p<0.0001). The efficacy of the combination in patients with previously untreated renal cell carcinoma with favorable-risk disease was not established.

The recommended schedule and dose for this combination is nivolumab, 3 mg/kg, followed by ipilimumab, 1 mg/kg, on the same day every 3 weeks for 4 doses, then nivolumab, 240 mg, every 2 weeks or 480 mg every 4 weeks.

Prescribing information for both nivolumab and ipilimumab have been updated with these results. Full prescribing information is available online: Nivolumab PI and Ipilimumab PI.

YOU MAY BE INTERESTED IN

In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models. 
The American Cancer Society’s recent report on the increasing incidence rates of colorectal cancer in young adults once again rang an alarm bell for adults over 45 to get checked, especially if they are having symptoms. But as an oncologist with more than 40 years of experience, I also believe that this should be a clarion call to scientists and researchers, and for regulators at the FDA.

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login