The Korean government has approved Ono Pharma Korea and Bristol-Myers Squibb Korea to sell Opdivo (nivolumab)-Yervoy (ipilimumab) combination therapy as the first-line immunotherapy to treat renal cell carcinoma (RCC).
The Ministry of Food and Drug Safety on Aug. 29 granted the nod for the combo to treat patients with moderate- and high-risk advanced RCC who were untreated previously.
The indication is the first that was granted on immunotherapy.
The approval based itself on a clinical trial called CheckMate-214, which evaluated the Opdivo-Yervoy combo in patients with moderate- and high-risk advanced RCC who did not have any treatment experience.
The study showed the combined therapy proved effective in achieving improved survival compared to sunitinib (under trade name Sutent by Pfizer), regardless of PD-L1 (programmed death-ligand 1) expression.
The monotherapy of Opdivo won approval on Aug. 29 last year for patients with progressive RCC whose previous treatments failed.
On April 16, the U.S. Food and Drug Administration recognized the Opdivo-Yerboy combo as the first-line treatment for patients with moderate- and high-risk advanced RCC who were untreated previously.
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