The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo Qvantig for subcutaneous use to treat various solid tumours.
This new combination product, which includes nivolumab co-formulated with recombinant human hyaluronidase, is intended for use in most previously approved adult solid tumour indications of Opdivo.
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Opdivo Qvantig can be used as monotherapy, monotherapy maintenance following treatment with Opdivo plus Yervoy (ipilimumab) combination regimen, or along with chemotherapy or cabozantinib.
The approval is based on the results from the Phase III CheckMate-67T trial.
This randomised, open-label study compared Opdivo Qvantig to intravenous (IV) Opdivo in adults with advanced or metastatic clear cell renal cell carcinoma (ccRCC) who had received systemic therapy previously.
It demonstrated that the treatment with Opdivo Qvantig had non-inferior co-primary pharmacokinetic exposures and similar efficacy in overall response rate (ORR), maintaining a comparable safety profile to IV Opdivo.
Subcutaneous administration of Opdivo Qvantig may provide increased flexibility for treatment locations, benefiting both patients and healthcare providers, the company noted.
It also has the potential to streamline preparation and reduce the time needed for administration.
During the CheckMate-67T trial, the average administration time for Opdivo Qvantig was approximately five minutes compared to the 30-minute IV administration of Opdivo.
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.”
In October this year, BMS received approval from the US FDA for Opdivo to treat adults with resectable non-small cell lung cancer.
