Don't miss real-time top news, insights, and interviews with the experts direct from the conference floor in Chicago. Sign up now to be reminded to tune in to OncLive News Network: On Location in Chicago.

FDA Grants Priority Review to Polatuzumab Vedotin Combination for R/R DLBC

KRISTIE L. KAHL
Tuesday, February 19, 2019
The FDA granted a priority review to polatuzumab vedotin in combination with bendamustine plus rituximab (Rituxan; BR) for the treatment of patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), according to Genentech, the anti-CD79b antibody drug conjugate’s manufacturer.

The biologic license application was based on results from the global, randomized phase Ib/II GO29365 study, designed to evaluate the safety, tolerability and activity of polatuzumab vedotin in combination with BR or obinutuzumab (Gazyva) in R/R follicular lymphoma or DLBCL. The primary endpoint was complete response (CR) at the end of treatment, while secondary endpoints included objective response (ORR) by investigator assessment and best objective response at the end of treatment by investigator and independent review committee assessment. Exploratory endpoints included duration of response (DOR), progression-free survival (PFS), event-free survival (EFS), and overall survival (OS).

“Polatuzumab vedotin, a potential first-in-class antibody drug conjugate, in combination with bendamustine and Rituxan, improved clinical outcomes including survival in some people with relapsed or refractory diffuse large B-cell lymphoma compared to bendamustine and Rituxan alone,” Sandra Horning, M.D., chief medical officer and head of global product development, said in a

Talk about this article with nurses and others in the oncology community in the General Discussions Oncology Nursing News discussion group.
External Resources

MJH Associates
American Journal of Managed Care
Cure
MD Magazine
Pharmacy Times
Physicians' Education Resource
Specialty Pharmacy Times
TargetedOnc
OncNurse Resources

Newsroom
Continuing Education
Discussions
Web Exclusives


About Us
Advertise
Advisory Board
Careers
Contact Us
Privacy Policy
Terms & Conditions
Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-716-4747

Copyright OncNursing 2006-2018
Intellisphere, LLC. All Rights Reserved.