FDA Approvals

The US FDA approved neoadjuvant durvalumab plus gemcitabine-cisplatin followed by adjuvant durvalumab after radical cystectomy for patients with muscle invasive bladder cancer.

Based on results from the PSMAfore trial, the FDA has expanded the approval of lutetium Lu 177 vipivotide tetraxetan to include patients with PSMA-positive metastatic castration-resistant prostate cancer previously treated with ARPIs and...

Based on results from the CABINET trial, the FDA has approved cabozantinib for patients 12 years of age and older with unresectable locally advanced or metastatic well-differentiated pNETs and epNETs who experienced disease progression after...

Based on results from the KEYNOTE-811 study, the FDA has approved first-line pembrolizumab plus trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy for patients with locally advanced, unresectable, or metastatic HER2-positive...

On February 14, 2025, the US Food and Drug Administration approved vimseltinib for patients with symptomatic tenosynovial giant cell tumor not amenable to surgical resection.

On February 11, 2025, the US Food and Drug Administration approved brentuximab vedotin with lenalidomide and rituximab for patients with relapsed or refractory diffuse large B-Cell lymphoma.

ased on results from the phase 2b ReNeu trial, the FDA has approved mirdametinib for adult and pediatric patients 2 years of age and older who have neurofibromatosis type 1-associated symptomatic plexiform neurofibromas not amenable to...

On January 21, 2025, the FDA approved treosulfan with fludarabine prior to allogeneic hematopoietic stem cell transplantation for patients with acute myeloid leukemia or myelodysplastic syndrome.

Based on results from the phase 3 DESTINY-Breast 06 trial, the FDA has approved trastuzumab deruxtecan for patients with HR-positive, HER2-low or HER2-ultralow unresectable or metastatic breast cancer who experienced disease progression on or...

The US Food and Drug Administration approved datopotamab deruxtecan for the treatment of patients with unresectable or metastatic, HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy in...