Bristol-Myers Squibb (BMY) Announces Receipt of Positive CHMP Opinion for Opdivo as r/r cHL Post-ASCT Treatment
Get instant alerts when news breaks on your stocks. Claim your 2-week free trial to StreetInsider Premium here.
Bristol-Myers Squibb Company (NYSE: BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of Opdivo (nivolumab) for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) after autologous stem cell transplant (ASCT) and treatment with brentuximab vedotin. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
“We recognize the enormous challenges facing classical Hodgkin lymphoma patients who do not respond to or who progress following currently available treatments, and we are dedicated to helping these patients in their fight against this devastating disease,” said Emmanuel Blin, senior vice president and chief strategy officer, Bristol-Myers Squibb. “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.”
The CHMP positive opinion is based on data from the Phase 2 CheckMate -205 and the Phase 1 CheckMate -039 trials, evaluating patients with relapsed or refractory cHL after ASCT and treatment with brentuximab vedotin. These results showed Opdivo delivered an objective response rate, as assessed by an independent radiologic review committee, of 66%. In CheckMate -205 and -039, among all patients (safety population: n=263), the most common adverse events (reported in at least 20%) were fatigue (32.3%), diarrhea (28.9%), pyrexia (27.1%) and cough (25.9%).
About Classical Hodgkin Lymphoma
Hodgkin lymphoma (HL), also known as Hodgkin disease, is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. In the European Union, about 12,200 new cases and 2,600 deaths occurred in 2012 as a result of HL. The disease is most often diagnosed in early adulthood (ages 20-40) and late adulthood (older than 55 years of age). Classical Hodgkin lymphoma is the most common type of HL, accounting for 95% of cases. There remains a significant unmet need for patients who relapse or who become refractory to approved treatments that are currently available.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- American Express (AXP) Elects John Brennan to Board of Directors
- Perrigo (PRGO) Reports FDA Approval of First-To-File AB Rated Generic Version of Topicort Spray, 0.25%
- Bristol-Myers Squibb Co. (BMY) PT Lowered to $58 at Barclays
Create E-mail Alert Related CategoriesCorporate News, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!