The Committee on Medicinal Products for Human Use (CHMP) has handed down a pair of positive opinions of Opdivo and AbbVie’s leukemia therapy in their quests for EMA approval.
Before the European Commission reviews an application for market authorization, it crosses the collective desk of the Committee on Medicinal Products for Human Use (CHMP). If all goes well, CHMP will grant a scientific recommendation to the EC for conditional marketing authorization. This is a key step along the road to attaining approval by the EMA, and both Opdivo, BMS’s struggling checkpoint inhibitor, and Venclyxto, AbbVie’s new leukemia B cell therapy, have both made it.
This comes as especially good news for Opdivo, which is now seen as a loser in the immuno-oncology space since BMS turned up nearly empty-handed to ESMO last week. BMS has been casting about for appropriate indications after the drug failed to outperform chemotherapy in lung cancer trials; CHMP’s positive opinion of Opdivo in classical Hodgkin lymphoma (cHL) may help it find its feet.