US FDA to decide sooner on SC Opdivo, another Halozyme collab

A new subcutaneous version of the checkpoint blocker Opdivo (nivolumab) could be approved earlier than expected, after the US regulator brought forward the date for a decision.

Bristol Myers Squibb (NYSE: BMY) is developing the product using Halozyme’s (Nasdaq: HALO) proprietary recombinant human hyaluronidase.

If approved, the more patient-friendly jab would be available across all adult, solid tumor Opdivo indications, either as monotherapy; monotherapy maintenance following combo treatment with Yervoy (ipilimumab); or in other combinations.