FDA Approvals

The FDA approved amivantamab plus carboplatin and pemetrexed for patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 19 deletions or exon 21 L858R substitution mutations and disease progression on or...

On September 12th, 2024, the US FDA approved subcutaneous coformulation of atezolizumab plus hyaluronidase for adult patients with non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part...

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.