Subcutaneous Opdivo moving closer to boost BMS

The prospect of a subcutaneous version of Bristol Myers Squibb’s (NYSE: BMY) immuno-oncology blockbuster Opdivo (nivolumab) has moved closer.

This comes with the news that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for this formulation of Opdivo - co-formulated with Halozyme Therapeutics’ (Nasdaq: HALO) proprietary recombinant human hyaluronidase (rHuPH20).

"An injection administered in three-to-five minutes rather than a 30-to-60-minute infusion"The agency has accepted the filing, which is based on Phase III data, across all previously-approved adult, solid tumor indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combinations, or in combination with chemotherapy or cabozantinib.