The Committee for Medicinal Products for Human Use, an arm of the European Commission, has recommended Bristol-Myers Squibb's Opdivo for approval, subject to final review by the full commission.
Opdivo, is a drug for treatment of squamous cell cancer in the head and neck, according to a Bristol-Myers Squibb press release.
Results of a Phase III clinical trial involving 25,000 patients, the final stage of testing before a drug hits the market, convinced the CHMP to recommend the medication, which is already sold in the U.S. and 60 other countries, the release said.
Squamous cell cancer of the mouth, nose and throat, the specific cancer targeted by Opdivo, is aggressive because it often doesn’t stay in remission after platinum and other therapies have been tried, Emmanuel Blin, the company’s senior vice president and chief strategy officer, said in the release.
“Nearly half of all patients with squamous cell cancer of the head and neck relapse within two years of treatment, and limited advancements have been made in the last 10 years, underscoring the critical need for new treatment options for patients affected by this devastating illness," Blin said.
Worldwide, squamous cell head and neck cancers affect approximately a half million new cases annually, causing around a quarter-million deaths each year, the release stated.
