US-based biopharmaceutical company Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced on Monday US Food and Drug Administration (FDA) approval for Bristol Myers Squibb's Opdivo Qvantig, co-formulated with Halozyme's ENHANZE technology, for subcutaneous administration across most adult solid tumour indications previously approved for intravenous Opdivo.

Opdivo Qvantig is the first subcutaneous PD-1 inhibitor, offering a three- to five-minute administration time compared to 30 minutes for intravenous delivery. This innovation enhances flexibility for treatment locations, reduces preparation steps, and shortens administration time.

Approval follows the Phase 3 CheckMate-67T trial, which confirmed noninferiority of Opdivo Qvantig to intravenous Opdivo in pharmacokinetic measures and demonstrated a comparable overall response rate (24% vs. 18%). Serious adverse reactions occurred in 28% of patients, with most common reactions including musculoskeletal pain, fatigue and rash. Fatal adverse reactions were reported in 1.2% of patients, including myocarditis, myositis and colitis complications. Discontinuation due to adverse effects occurred in 10% of cases. The safety profile aligns with that of intravenous Opdivo.