Halozyme Says FDA Approved Bristol Myers's Opdivo Qvantig With ENHANZE For Subcutaneous Use

(RTTNews) - Halozyme Therapeutics, Inc. (HALO) Monday said that the Food and Drug Administration (FDA) has approved Bristol Myers Squibb's Opdivo Qvantig co-formulated with Halozyme's ENHANZE drug delivery technology for subcutaneous use in most previously approved adult, solid tumor Opdivo indications.

Opdivo Qvantig with ENHANZE has been approved as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.

The FDA approval is based on positive results from the Phase 3 CheckMate-67T study, evaluating Opdivo Qvantig co-formulated with Halozyme's ENHANZE, compared to intravenous Opdivo, in adults with clear cell renal cell carcinoma. Opdivo Qvantig also showed a comparable safety profile to IV OPDIVO.