United States-based Bristol-Myers Squibb has received approval from the US Food and Drug Administration (FDA) for a four-week dosing schedule for the company's Opdivo cancer drug, it was reported yesterday.
The regulator approved the product label update offering flexible flat-dosing options every two weeks (240 mg) or every four weeks (480 mg). The product, which is a programmed death-1 (PD-1) inhibitor, was earlier approved as a two-week dosing schedule for dosage strength of 240mg for the treatment of various cancers including melanoma, non–small cell lung cancer, and renal cell carcinoma. The US FDA has also approved the product for a shorter 30-minute infusion for all of its approved indications.
The company stated that it is likely to submit dosing schedule updates for an additional approved indication to the regulator in the future.
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