Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) in previous Opdivo indications.
Opdivo (nivolumab) is a programmed death-1 (PD-1) immune checkpoint inhibitor that helps the body’s own immune system fight against cancer and restore immune response.
Opdivo Qvantig is a combination of Opdivo, co-formulated with recombinant human hyaluronidase (rHuPH20), administered as a subcutaneous injection.
The US FDA approved Opdivo Qvantig as monotherapy in most previously approved indications of Opdivo to treat solid tumours in adults.
Also, the drug is indicated as monotherapy maintenance after Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib.
Bristol Myers Squibb executive vice president and chief commercialisation officer Adam Lenkowsky said: “At Bristol Myers Squibb, we are committed to helping patients in all aspects of their healthcare journey.
“Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumour types. With this new option, we look forward to further helping cancer patients with an administration method that gives them faster delivery.”
The FDA approval is based on the results from CheckMate-67T, a Phase 3, randomised, open-label, noninferiority trial evaluating Opdivo Qvantig compared to Opdivo.
The Phase 3 study evaluated the drug in 495 adult patients with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who received prior systemic therapy.
In the study, Opdivo Qvantig showed similar efficacy in overall response rate (ORR) and a comparable safety profile compared to intravenous (IV) Opdivo.
According to the company, subcutaneous administration may reduce the steps required for preparation and time needed for administration.
With the FDA approval, Opdivo Qvantig becomes the first and only subcutaneously administered PD-1 inhibitor, offering a faster delivery option than Opdivo.
Roswell Park Comprehensive Cancer Centre network clinical trials director and medical oncologist Saby George said: “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.
“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.”
