Japan Approves World's First PD-1 Drug, Nivolumab | Melanoma Dispatch | Scoop.it

"Ono Pharmaceutical Co has become the first company in the world to get an approval for a PD-1 checkpoint inhibitor, as regulators in Japan gave the green light to nivolumab, developed with Bristol-Myers Squibb, as a treatment for melanoma.

"The drug will be marketed as Opdivo for unresectable melanoma although Ono noted that because of the very limited number of patients treated with nivolumab in Japanese clinical trials, the firm is required to perform a 'post-marketing use-results survey covering all cases until data on a certain minimum number of patients have been accumulated'."

Editor's note: The drug nivolumab is an immunotherapy, meaning that it boosts a patient's own immune system to fight cancer. Nivolumab is a specific kind of immunotherapy drug known as a "PD-1 checkpoint inhibitor," since it works by releasing a protein "brake" on the immune system called PD-1. Researchers testing the drug in volunteer patients have found promising results, and Japan has now given the world's first approval to nivolumab, permitting doctors across the country to prescribe it to people with unresectable melanoma.