Hyaluronidase (human recombinant)

Opdivo Qvantig, the first subcutaneously administered PD-1 inhibitor, received FDA approval for treating adult solid tumors. Co-formulated with Halozyme's ENHANZE technology, it offers faster administration and comparable efficacy and safety to IV Opdivo, as shown in the Phase 3 CheckMate-67T trial.

Opdivo Qvantig, the first subcutaneously administered PD-1 inhibitor, received FDA approval for treating solid tumors. It offers faster administration and comparable safety and efficacy to IV Opdivo, as shown in the Phase 3 CheckMate-67T trial.

Halozyme Therapeutics announced Takeda's HYQVIA® received Japanese regulatory approval for treating agammaglobulinemia or hypogammaglobulinemia, offering reduced dosing frequency with Halozyme's ENHANZE® technology.

The "Relapsed Multiple Myeloma - Global Clinical Trials Review, 2024" report offers an overview of clinical trials worldwide, detailing trials by region, country, phase, status, and sponsor type, including prominent drugs and companies involved.

In 2024, FDA approved several cancer treatments including Elahere for gynecologic cancers, Udenyca biosimilar for on-body administration, Onivyde for metastatic pancreatic cancer, Enhertu for HER2-positive solid tumors, and Darzalex Faspro for multiple myeloma, based on clinical trial results showing improved survival and response rates.

FDA approves encorafenib combo for BRAF V600E+ metastatic CRC, ensartinib for ALK+ NSCLC, issues CRL to subcutaneous amivantamab BLA in EGFR+ NSCLC, seeks EU approval for ibrutinib plus R-CHOP in frontline MCL, and grants breakthrough therapy designation to sacituzumab govitecan for second-line ES-SCLC.

FDA issued a complete response letter (CRL) for subcutaneous amivantamab-vmjw and recombinant human hyaluronidase in NSCLC with EGFR mutations due to manufacturing facility issues, not product formulation or efficacy. The CRL does not affect the current IV amivantamab approval. Johnson & Johnson is working with the FDA to resolve the issue. Subcutaneous amivantamab showed noninferior overall response rate (ORR) vs IV formulation in the phase 3 PALOMA-3 study, with FDA priority review granted in August 2024.

argenx SE, a biotech company, sees 85.56% revenue growth driven by VYVGART. The company is valued at $36.82 billion, with VYVGART Hytrulo approved for CIDP, targeting 12,000 patients. argenx aims for profitability by 2025 and has a robust pipeline, including efgartigimod for myositis and empasiprubart for dermatomyositis.

ASH 2024 highlights include GSK's Blenrep Phase 3 data supporting re-market, J&J's Darzalex Faspro delaying progression in smoldering multiple myeloma, Arcellx's anito-cel showing comparable safety to Carvykti, and J&J/Legend's Carvykti improving survival outcomes. Kura Oncology's ziftomenib showed high response rates in leukemia, Eli Lilly's Jaypirca reduced disease progression risk, and Merck's zilovertamab vedotin achieved high complete response rates in lymphoma. Beam Therapeutics' BEAM-101 showed durable effects in sickle cell disease, Novo Nordisk's etavopivat reduced crises, and Bristol Myers Squibb's arlo-cel demonstrated durable responses in multiple myeloma. Galapagos' GLPG5101 showed encouraging cell therapy results, Orca Bio's Orca-T improved survival in blood cancers, and Sanofi's rilzabrutinib improved platelet response in thrombocytopenia. Regeneron's drug combo showed better disease control than Ultomiris in PNH.