Bristol-Myers Squibb Receives Positive European Agency Opinion

Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended 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.

This is the first time the CHMP has recommended a PD-1 inhibitor as an adjuvant treatment for any type of cancer. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

“This positive opinion supports the potential of Opdivo in the adjuvant setting to prevent relapse and progression to an advanced stage,” said Arvin Yang, M.D., Ph.D., development lead, melanoma and genitourinary cancers, Bristol-Myers Squibb. “We look forward to the upcoming EC decision and the potential opportunity to bring Immuno-Oncology treatment options to more patients across the European Union.”

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 according to the AJCC Cancer Staging Manual 7th edition. The U.S. FDA expanded the approval of Opdivo to include the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection in December 2017.

(Source: Bristol-Myers Squibb)