FDA Approvals

The US Food and Drug Administration approved novel immunotherapy denileukin diftitox-cxdl for the treatment of patients with relapsed/refractory cutaneous T-cell lymphoma after at least 1 prior systemic therapy.

Based on results from the INDIGO trial, the FDA has approved vorasidenib for adult and pediatric patients 12 years and older with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation following surgery.

On August 2, 2024, the US Food and Drug Administration (FDA) granted accelerated approval to afamitresgene autoleucel for the treatment of adult patients with certain unresectable or metastatic synovial sarcomas who had received prior...

The FDA approved dostarlimab plus carboplatin and paclitaxel, followed by single-agent dostarlimab for patients with primary advanced or recurrent endometrial cancer.

The FDA granted approval daratumumab and hyaluronidase combined with bortezomib, lenalidomide, and dexamethasone for induction and consolidation for patients with newly diagnosed multiple myeloma eligible for ASCT.

The FDA has approved the new drug application for SH-105, a liquid formulation of thiotepa, for the treatment of patients with breast and ovarian cancer.

The FDA granted accelerated approval to epcoritamab-bysp for the treatment of adult patients with relapsed or refractory follicular lymphoma who received ≥2 prior lines of therapy.

Based on results from the phase 3 KEYNOTE-868/NRG-GY018 trial, the FDA has approved pembrolizumab plus carboplatin and paclitaxel followed by single-agent pembrolizumab for patients with primary advanced or recurrent endometrial cancer.

Based on results from the phase 3 DUO-E trial, the FDA has approved durvalumab plus carboplatin and paclitaxel followed by durvalumab maintenance for patients with primary advanced or recurrent mismatch repair deficient endometrial cancer.

Based on results from the LIBRETTO-001 and the LIBRETTO–121 studies, the FDA has approved selpercatinib for adult and pediatric patients with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are...