US regulators have approved a label update to Bristol-Myers Squibb’s Opdivo, waving through a new dosing option for the immunotherapy of every four weeks.
The company says the approval will allow physicians to customise patient care with the option of using the newly approved dose of 480mg every four weeks in addition to the previously available option of 240mg every two weeks.
The US Food and Drug Administration also approved Opdivo (nivolumab) for a shorter 30-minute infusion across all of its approved indications, the firm noted.
“With this approval, we now offer the most robust range of dosing options for an Immuno-Oncology medicine, providing enhanced flexibility to help address each patient's specific needs," said Johanna Mercier, head, US Commercial, BMS.
Opdivo is approved for various indications across melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), classical Hodgkin lymphoma (cHL), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma, microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) and hepatocellular carcinoma (HCC).