Hyaluronidase (human recombinant)

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.

Johnson & Johnson's Darzalex Faspro showed significant improvement in progression-free survival in high-risk smouldering multiple myeloma patients, with 63.1% remaining progression-free at 60 months vs 40.8% in active monitoring. Five-year survival rates were 93% with Darzalex Faspro vs 86.9% with monitoring, and response rates were 63.4% vs 2%. J&J has submitted regulatory applications based on these phase 3 AQUILA trial results.

Johnson & Johnson presents TECVAYLI data from MajesTEC-5 and MajesTEC-4 studies, showing potential in newly diagnosed multiple myeloma patients. Results include MRD negativity and manageable safety profiles, with further combination therapy analysis planned in MajesTEC-7.

Johnson & Johnson announces TECVAYLI® (teclistamab-cqyv) data showing 100% MRD negativity in newly diagnosed multiple myeloma patients treated with MajesTEC-5 induction and MajesTEC-4 maintenance therapies, presented at the 2024 ASH Annual Meeting.

DARZALEX FASPRO® significantly delayed progression from high-risk SMM to active MM and extended overall survival in the Phase 3 AQUILA study, compared to active monitoring.

Nuvig Therapeutics develops a first-in-class drug targeting type II Fc receptors to expand regulatory T cells, aiming to treat autoimmune diseases without chronic immunosuppression. The company secured $161 million for Phase 2 development of NVG-2089, tested for chronic inflammatory demyelinating polyneuropathy (CIDP). Unlike FcRn blockers, Nuvig's drug is immunomodulatory, potentially offering broader efficacy in CIDP.