BioCentury
ARTICLE | Company News

Bristol-Myers, Ono Pharmaceutical sales and marketing update

February 1, 2016 8:00 AM UTC

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) issued a dossier assessment addendum for Opdivo nivolumab from Bristol-Myers Squibb to treat BRAF V600 mutation-negative melanoma concluding that the added benefit is “major” in men and “considerable” in women. In October, IQWiG said the human IgG4 mAb against PD-1 has “considerable” added benefit in men and “minor” added benefit in women. IQWiG said the company submitted adequate additional analyses that showed an advantage over dacarbazine for serious adverse events. In October, IQWiG also said Opdivo had “no hint of added benefit” in other patient groups due to non-evaluable data provided by BMS.

Separately, the U.K.’s NICE issued final draft guidance recommending Opdivo to treat advanced melanoma. The committee did not issue draft guidance because the recommendation is in line with Opdivo’s approved indication. ...