Belantamab mafodotin

Blenrep (belantamab mafodotin) plus bortezomib and dexamethasone significantly improved overall survival, progression-free survival, minimal residual disease negativity rate, and duration of response compared to Darzalex plus the same in relapsed or refractory multiple myeloma patients, according to the DREAMM-7 trial results.

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.

New Amsterdam Pharma's CETP inhibitor succeeded in Phase 3 trials, GSK partnered with Relation for fibrotic disease and osteoarthritis drugs, Cardiff Oncology's CRDF-004 showed tumor shrinkage in metastatic colon cancer patients, and Cure Ventures launched Tasca Therapeutics with $52 million for cancer therapies. GSK's Blenrep showed improved survival in multiple myeloma patients, J&J's Darzalex may prevent myeloma in high-risk patients, and Uniqure received FDA approval to seek accelerated approval for Huntington's disease gene therapy.

GSK's Blenrep, an antibody-drug conjugate targeting BCMA in multiple myeloma, showed a 42% reduction in death risk when combined with chemotherapy and a steroid, compared to J&J's Darzalex. Despite initial market withdrawal, GSK is optimistic about Blenrep's potential comeback, supported by new survival data and ongoing studies. The drug could face competition from emerging cell therapies and bispecific antibodies, but GSK is exploring dosing options to enhance its profile.

GSK's Blenrep, a multiple myeloma drug, shows significant overall survival benefit in a Phase 3 study, potentially becoming a new standard of care treatment. The drug, an antibody drug conjugate targeting BCMA, demonstrated a 42% reduction in the risk of death compared to a standard regimen. Despite initial market withdrawal, new data supports its efficacy in earlier treatment lines, with ongoing FDA review expected in July.

Johnson & Johnson seeks approval for Darzalex to treat high-risk smoldering myeloma, with AQUILA trial showing reduced risk of disease progression. GSK's Blenrep, after withdrawal, shows improved survival in DREAMM-7 trial. Emerging efforts aim to ease conditioning for genetic treatments in sickle cell disease. Kura Oncology's menin inhibitor shows promising results in AML, facing competition from J&J and Syndax. Pfizer's Oxbryta withdrawal for sickle cell disease remains unexplained.

NMPA accepted GSK's NDA for Blenrep (belantamab mafodotin) in combination with bortezomib plus dexamethasone for relapsed or refractory multiple myeloma, based on DREAMM-7 trial results showing significant efficacy, including overall survival. This marks the seventh major regulatory filing acceptance for belantamab mafodotin combinations this year.

The FDA accepted GSK's BLA for Blenrep in combination with bortezomib plus dexamethasone (BVd) and pomalidomide plus dexamethasone (BPd) for relapsed or refractory multiple myeloma, supported by Phase III DREAMM-7 and DREAMM-8 trials. Blenrep combinations showed clinically meaningful improvements in efficacy endpoints, with manageable side effects. The FDA action date is set for July 23, 2025.

Belantamab mafodotin's comeback, FDA approvals for subcutaneous daratumumab-hyaluronidase and expanded CAR T-cell products, and isatuximab-based quadruplet emerging as new standard for transplant-ineligible newly diagnosed multiple myeloma patients.