European CHMP Recommends Expansion of Current Indications of Opdivo to Include Adjuvant Therapy in Resected Melanoma.
M2 PHARMA-July 6, 2018-European CHMP Recommends Expansion of Current Indications of Opdivo to Include Adjuvant Therapy in Resected Melanoma
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- New York, New York-based biopharmaceutical company Bristol-Myers Squibb (NYSE: BMY) has received a recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for expanded approval of the current indications for Opdivo (nivolumab) to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, the company said.
The CHMP recommendation is based on data from the phase 3 CheckMate -238 trial, an ongoing, randomized double-blind study of Opdivo 3 mg/kg versus Yervoy (ipilimumab) 10 mg/kg in patients who have undergone complete resection of stage IIIB/C or stage IV melanoma.
Patients in CheckMate -238 were treated until disease recurrence, unacceptable toxicity, or withdrawal of consent for up to one year. The primary endpoint is recurrence-free survival after which the trial will continue to evaluate for overall survival, a secondary endpoint.
Opdivo is a programmed death-1 immune checkpoint inhibitor that is designed to uniquely harness the body's own immune system to help restore anti-tumor immune response.
Bristol-Myers Squibb's mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
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|Date:||Jul 6, 2018|
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