Bristol Myers Squibb (BMS) has announced that an injectable form of its cancer immunotherapy Opdivo (nivolumab) has been approved by the US Food and Drug Administration (FDA).
Opdivo Qvantig, which co-formulates nivolumab with recombinant human hyaluronidase, has been authorised for subcutaneous (SC) use in most previously approved adult, solid tumour intravenous (IV) Opdivo indications.
This includes certain cases of renal cell carcinoma (RCC), melanoma, non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck, urothelial carcinoma, oesophageal or gastroesophageal junction cancer, oesophageal squamous cell carcinoma and gastric cancer.
The FDA’s decision was supported by positive results from the late-stage CheckMate-67T trial, in which Opdivo Qvantig demonstrated consistent efficacy and showed a comparable safety profile to IV Opdivo in adults with advanced or metastatic clear cell RCC who had received prior systemic therapy.
It is hoped that the SC formulation will be more convenient for patients, reducing the steps required for preparation and offering an average administration time of three to five minutes compared to 30 minutes for the drug’s IV form.
Adam Lenkowsky, executive vice president and chief commercialisation officer at BMS, said: “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.”
Opdivo is designed to use the body’s own immune system to help restore anti-tumour immune response.
Its latest approval comes less than three months after the FDA approved IV Opdivo as part of a perioperative treatment regimen for adults with resectable NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements.
This was based on positive results from the phase 3 CheckMate-77T trial, in which Opdivo alongside platinum-doublet chemotherapy as a neoadjuvant treatment before surgery and as an adjuvant monotherapy after surgery was shown to improve event-free survival compared to chemotherapy plus placebo.
BMS also recently announced positive ten-year follow-up data from a late-stage study evaluating Opdivo in combination with its human monoclonal antibody Yervoy (ipilimumab) in patients with previously untreated advanced or metastatic melanoma.