FDA, Immuno-oncology

Bristol-Myers’ nivolumab grabs its sixth breakthrough designation as new links to autoimmune diseases creep up

This morning the FDA handed out its 6th “breakthrough” drug designation for Bristol-Myers Squibb’s Opdivo (nivolumab), signaling once again the agency will continue to facilitate the checkpoint inhibitor’s rapid rollout in the oncology market.

Checkpoint inhibition has become BMS’ specialty, zipping ahead of Merck’s Keytruda (pembrolizumab) in the PD-1 arena as physicians glom on to this new treatment paradigm for orchestrating an immune system assault on cancer cells.

But as the drugs gain greater traction, there’s new evidence revving up the immune system has unintended consequences that could threaten a slice of the patient population.

Johns Hopkins has now stepped up with 13 case studies that link nivolumab and Yervoy (ipilimumab) to cases of inflammatory arthritis and other autoimmune conditions. And doctors expect to see that caseload grow as even more checkpoints are approved for wider use against cancer.

Dr. Clifton Bingham, courtesy of Johns Hopkins.

Dr. Clifton Bingham, courtesy of Johns Hopkins.

“We keep having referrals coming in from our oncologists as more patients are treated with these drugs,” says Clifton Bingham, M.D., associate professor of medicine at the Johns Hopkins University School of Medicine and director of the Johns Hopkins Arthritis Center. “In particular, as more patients are treated with combinations of multiple immunotherapies, we expect the rate to go up.”

None of that will prevent the use of these drugs in the cancer field, which has embraced checkpoint inhibition as a major advance in slowing or even halting cancer. The FDA’s latest Breakthrough Therapy Designation for nivolumab covers an advanced form of bladder cancer.


The best place to read Endpoints News? In your inbox.

Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.

Free Subscription

RAPS Regulatory Convergence 2017