FDA Updates PDUFA Date of BLA for Subcutaneous Nivolumab in Advanced or Metastatic Solid Tumors

The FDA has updated the Prescription Drug User Fee Act (PDUFA) target action date for the biologics license application (BLA) seeking the approval of nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20; subcutaneous nivolumab) for the treatment of adult patients eligible for previously approved solid tumor nivolumab indications as monotherapy, monotherapy maintenance following completion of nivolumab plus ipilimumab (Yervoy) combination therapy, or in combination with chemotherapy or cabozantinib (Cabometyx).1