The CHMP positive opinion was based on overall response rate (ORR) demonstrated by data from two trials, CheckMate -205 and CheckMate -039.
Opdivo delivered an ORR, as evaluated by an independent radiologic review committee, of 66%
In both the trials, among all patients, the most common adverse events were fatigue (32.3%), diarrhea (28.9%), pyrexia (27.1%) and cough (25.9%).
The CHMP recommendation will now be reviewed by the European Commission, which usually issues its final approval decision within two to three months.
Bristol-Myers Squibb senior vice president and chief strategy officer Emmanuel Blin said: “Today’s CHMP positive opinion marks an important milestone in applying our Immuno-Oncology science to delivering a treatment option for patients with this hematologic malignancy.
“If approved by the European Commission, Opdivo will become the first PD-1 inhibitor approved to treat a hematologic malignancy in the European Union, further building on our established heritage in blood cancer care.”
Last month, the EMA validated BMS’ type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.
Opdivo targets the cellular pathway known as PD-1/PD-L1 proteins identified on the body's immune cells and various cancer cells. The blocking of the pathway helps the body's immune system fight cancer cells.
Image: Bristol-Myers Squibb facility in Brussels, Belgium. Photo: courtesy of Bristol-Myers Squibb Company.