Korea ap­proves Op­divo-Yer­voy for re­nal cell car­ci­noma

BioSpectrum (Asia) - - Regulatory News -

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 ap­proval is based 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.

L-R- Liu Baochun, Di­rec­tor-Gen­eral Guangzhou For­eign Af­fairs Of­fice, China ex­chang­ing doc­u­ment with Pene Baleinab­uli, Of­fi­cial Sec­re­tary to the Fiji’s Pres­i­dent- Jioji Kon­rote.

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