Injectable version of Bristol Myers Squibb cancer drug Opdivo gets USFDA okay

“This approval of subcutaneous nivolumab gives our patients a new option that can deliver consistent efficacy and comparable safety expected from IV nivolumab, and offers a patient-centric treatment experience,” said Professor Dr. Saby George, MD, FACP, medical oncologist and director of network clinical trials at Roswell Park Comprehensive Cancer Center. “ Opdivo Qvantig offers faster administration, delivered in three to five minutes. It may allow patients, in consultation with their doctors, to choose another treatment method and the flexibility to receive treatment closer to home.”

In the trial, noninferiority was demonstrated for the co-primary endpoints of time-averaged concentration over 28 days (C_avgd28) and minimum concentration at steady state (C_minss) of Opdivo Qvantig vs. IV Opdivo . The geometric mean ratios (GMRs) for C_avgd28 was 2.10 (90% CI: 2.00-2.20) and the GMR for C_minss was 1.77 (90% CI: 1.63-1.93). As a key powered secondary endpoint, the overall response rate (ORR) in the Opdivo Qvantig arm (n=248) was 24% (95% CI: 19-30) compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247), showing that Opdivo Qvantig has similar efficacy compared to IV Opdivo.

Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their providers, and may reduce steps required for preparation and time needed for administration. In the CM–67T trial, average administration time with Opdivo Qvantig was approximately five minutes, and most patients received all doses of the study medication without an injection interruption or dose delay.

With this approval, Opdivo Qvantig is now a subcutaneously administered PD-1 inhibitor, offering a faster delivery for patients to receive this immunotherapy treatment option in three to five minutes compared to 30-minute IV Opdivo .

Opdivo and Opdivo Qvantig are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo or Opdivo Qvantig are added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. Opdivo is associated with infusion related reactions.

“At Bristol Myers Squibb, we are committed to helping patients in all aspects of their healthcare journey,” said Adam Lenkowsky, executive vice president and chief commercialization officer. “Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types. With this new option, we look forward to further helping cancer patients with an administration method that gives them faster delivery.”

“Receiving a cancer diagnosis can be frightening and stressful,” said Audrey Davis, LPC and Senior Director of Programs and Health Equity at the Cancer Support Community. “Having a treatment option that may offer patients flexibility to receive treatment outside of traditional hospital settings and reduce the administration time is important. It’s exciting to see these continued advancements with immunotherapy administration that may offer another choice for patients and caregivers navigating this difficult journey.”