News >

FDA Approves Nivolumab/Ipilimumab Combination for BRAF Wild-Type Melanoma

Silas Inman @silasinman
Published: Thursday, Oct 01, 2015

Dr. Jedd D. Wolchok

Jedd D. Wolchok, MD, PhD

The FDA has granted an accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) as a treatment for patients with BRAF V600 wild-type unresectable or metastatic melanoma, based on findings from the phase II CheckMate-069 study.

The most frequently observed AEs with the combination versus the single-agent were colitis (17% vs 9%), diarrhea (9% vs 7%), pyrexia (6% vs 7%), and pneumonitis (5% vs 0). The most common AEs with the combination versus the single-agent, respectively, were rash (67% vs 57%), pruritus (37% vs 26%), headache (24% vs 20%), vomiting (23% vs 15%), and colitis (22% vs 11%).

“Today’s approval of the Opdivo plus Yervoy Regimen marks another first for our research in immuno-oncology and represents our unwavering commitment to continually redefine cancer care, and offer patients new treatment options with the goal of improved outcomes,” Giovanni Caforio, chief executive officer, Bristol-Myers Squibb, the company developing the drugs, said in a statement.

Nivolumab and ipilimumab are each FDA-approved as single-agents for the treatment of patients with unresectable or metastatic melanoma. In addition to melanoma, the FDA approved nivolumab in March 2015 as a treatment for patients with metastatic squamous non-small cell lung cancer following a platinum-based chemotherapy.

“Targeting the immune system in the treatment of cancer has been of interest to the oncology community for decades, and our first immuno-oncology agent, Yervoy, was approved in 2011 for metastatic melanoma,” said Caforio. “Opdivo reinforced the power of the immune system in the fight against cancer, and is quickly becoming a foundational component in how the oncology community treats this devastating disease.”

Hodi FS, Postow MA, Chesney J, et al. Improved clinical response in patients with advanced melanoma treated with nivolumab combined with ipilimumab compared to ipilimumab alone. Presented at: 2015 AACR Annual Meeting; April 18-22; Philadelphia, PA. Abstract 4214.

 

... to read the full story
To Read the Full Story

View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Advances in™ Melanoma: Exploring BRAF/MEK in Adjuvant and Neoadjuvant SettingsSep 28, 20191.5
Medical Crossfire®: What Does Data Tell Us About How to Optimize Checkpoint Inhibitor Strategies Across Lines of Care for Patients with Melanoma?Nov 30, 20191.5
Publication Bottom Border
Border Publication
External Resources

MJH Associates
American Journal of Managed Care
Cure
MD Magazine
Oncology Nursing News
Pharmacy Times
Physicians' Education Resource
Physician's Money Digest
Specialty Pharmacy Times
TargetedOnc
OncLive Resources

Articles
Blogs
Conference Coverage
OncLive TV
Peer Exchange
Publications
Specialties
Web Exclusives


About Us
Advertise
Advisory Board
Careers
Contact Us
Forgot Password
Press Releases
Privacy Policy
Terms & Conditions
 
Intellisphere, LLC
2 Clarke Drive
Suite 100
Cranbury, NJ 08512
P: 609-716-7777
F: 609-939-0221

Copyright OncLive 2006-2018
Intellisphere, LLC. All Rights Reserved.
 
x