EMA’s CHMP recommends new dosing schedule for Opdivo in melanoma

pharmafile | September 25, 2019 | News story | Research and Development, Sales and Marketing |  BMS, Bristol-Myers Squibb, CHMP, EMA, melanoma, opdivo, pharma 

Bristol-Myers Squibb has revealed that its blockbuster immunotherapy drug Opdivo (nivolumab) has secured recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for a new dosing schedule in the adjuvant treatment of specific patients with melanoma.

The recommendation concerns adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. The panel chose to recommend the authorisation of a flat dosing schedule of Opdivo 240mg infused over 30 minutes every two weeks or 480mg infused over 60 minutes every four weeks.

The decision could lead to an eventual approval from the EMA, which, though not bound by the recommendation, generally follows the advice of the panel.

“This positive CHMP opinion for Opdivo two and four-week dosing reinforces our commitment to offering flexible dosing options for patients, caregivers and healthcare providers,” said Dr Ralu Vlad, Development Team Lead, Product Design and Delivery, Bristol-Myers Squibb. “We look forward to the European Commission’s decision and potentially bringing this new Opdivo dosing regimen to patients as quickly as possible.”

Matt Fellows