MSK Research Drives 11 FDA Cancer Drug Approvals in 2025
Memorial Sloan Kettering-led trials produced 11 new FDA-approved cancer therapies in a single year, spanning multiple tumor types.
20 articles
Memorial Sloan Kettering-led trials produced 11 new FDA-approved cancer therapies in a single year, spanning multiple tumor types.
FDA approves an updated Spinraza regimen for spinal muscular atrophy, targeting improved CSF drug levels for better neurological outcomes.
Sonrotoclax (Beqalzi), a next-gen BCL-2 inhibitor, wins accelerated FDA approval for relapsed or refractory MCL after BTK inhibitor failure.
A roundup of recent FDA brain-health approvals including lecanemab's full Alzheimer's approval and a new glioma drug.
From Alzheimer's to Parkinson's, a wave of novel FDA approvals is expanding treatment options for serious neurological conditions.
Avlayah becomes the first treatment targeting neurologic symptoms of rare genetic disorder affecting 500 Americans.
Two breakthrough approvals target Hunter syndrome brain complications and cerebral folate deficiency for the first time.
Avlayah (tividenofusp alfa-eknm) becomes the first therapy approved to address brain damage in Hunter syndrome, a rare pediatric disorder.
MSK-led research drove 10 FDA cancer drug approvals in 2025, including nivolumab combined with chemotherapy for classical Hodgkin lymphoma.
Inqovi gains approval for newly diagnosed AML in patients 75+ or with comorbidities, offering a gentler oral treatment route.
Sevabertinib and zongertinib win FDA approval for HER2-mutant NSCLC, expanding targeted therapy options for previously treated patients.
Wellcovorin becomes the first approved treatment for cerebral folate deficiency tied to FOLR1 gene variants, offering hope for a rare neurological condition.
Zongertinib and sevabertinib earn FDA accelerated approvals for HER2-mutant NSCLC, expanding targeted therapy options for a historically hard-to-treat subset.
The FDA approved zenocutuzumab-zbco for adults with advanced, unresectable, or metastatic cholangiocarcinoma, a rare and aggressive bile duct cancer with limited treatment options.
Zongertinib (Hernexeos) wins FDA approval for unresectable or metastatic HER2-mutant non-squamous NSCLC, expanding targeted therapy options.
Zongertinib (Hernexeos) wins accelerated FDA approval for metastatic NSCLC with HER2 tyrosine kinase domain mutations, filling a critical treatment gap.
New targeted therapy offers hope for patients with specific genetic mutations in non-small cell lung cancer.
Nivolumab plus standard chemotherapy receives FDA approval for classical Hodgkin lymphoma, expanding immunotherapy's role in blood cancers.
The FDA expanded accelerated approval for zongertinib in HER2-mutant NSCLC, marking a targeted therapy milestone for a hard-to-treat mutation.
Pembrolizumab plus chemotherapy gains FDA approval for PD-L1-positive ovarian cancer patients who failed prior treatment.