The European Commission has approved a new dosing schedule for Opdivo (nivolumab), allowing the PD-1 inhibitor to be given every four weeks to patients with advanced melanoma and those with previously treated renal cell carcinoma.
The approval means that physicians may now choose to prescribe the medicine either as a 480 mg, 60-minute infusion every four weeks, or as a 240 mg infusion given over 30 minutes every two weeks. This two-week dose is an option replacing weight-based dosing for all six of its approved uses across the European Union.
Opdivo is the first and only PD-1 inhibitor approved in the EU to offer every four-week dosing as a treatment option.
“This approval marks a significant achievement in our longstanding commitment to providing patients and healthcare providers with more flexible and convenient treatment options,” Fouad Namouni, MD, head of development, oncology, at Bristol-Myers Squibb, said in a press release. “[W]e will now be able to offer a range of dosing options for an immuno-oncology medicine approved in the European Union.”
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor designed to harness the immune system to help restore anti-tumor immune response. It is currently approved in more than 60 countries, including the United States, the European Union and Japan. Alone or in combination, it is approved to treat a number of advanced cancers, including certain melanomas, renal cell carcinomas, and non-small cell lung cancers.
The European Commission’s approval of the new dosing schedule follows a positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in March.
Similar Opdivo dosing options were approved by the U.S. Food and Drug Administration (FDA) in March, based on a study of their safety and effectiveness.
The study, presented during the American Association for Cancer Research Annual Meeting 2017, showed that patients with melanoma and renal cell carcinoma who received 480 mg of Opdivo every four weeks had similar predicted objective tumor responses to patients who received every two-week dosing.
The two- and four-week dosing regimens are being compared in Phase 3 trial in people with metastatic non-small cell lung cancer (NCT02713867) that is recruiting at sites across the U.S., Canada, Australia, and Europe. More information is available by clicking on the study’s identification number.
