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Bristol-Myers Squibb Co

Bristol-Myers Squibb’s new dosing for cancer drug Opdivo gets FDA green light

The approval is for a supplemental Biologics Licence Application which updates the Opdivo (nivolumab) dosing schedule to include 480 mg infused every four weeks

cancer
Johanna Mercier, head, U.S. Commercial, Bristol-Myers said: “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.”

Bristol-Myers Squibb Co (NYSE:BMY) said the US Food and Drug Administration (FDA) has given the green light for a new dosing schedule for its drug Opdivo, for a number of cancers that it is already approved for.

The approval is for a supplemental Biologics Licence Application (sBLA) which updates the Opdivo (nivolumab) dosing schedule to include 480 mg infused every four weeks.

READ: Bristol-Myers shares on the uptick after positive lung cancer trial results and market beating fourth quarter results

Opdivo is already approved for every two weeks at 240 mg and for a shorter 30-minute infusion across all approved indications.

The company said in a statement that the dosing schedule updates for an additional approved indication may be submitted to the FDA in the future.

Jeffrey S Weber, the deputy director of the Perlmutter Cancer Center at NYU Langone Health: “… some patients may need the support of two-week visits with their health care team, while for others, a four-week interval may be more appropriate and better suited to their treatment needs. With this approval, we now have additional ways to help tailor patient care.”

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