FDA Approvals

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...

The U.S. Food and Drug Administration granted approval to lisocabtagene maraleucel for adult patients with relapsed or refractory MCL who have received at least 2 prior lines of systemic therapy including a BTK inhibitor.

The US Food and Drug Administration granted accelerated approval to lisocabtagene maraleucel for adult patients with relapsed or refractory follicular lymphoma who have received 2 or more prior lines of systemic therapy.

Based on results from the phase 3 innovaTV 301 trial, the FDA has approved tisotumab vedotin for patients with recurrent or metastatic cervical cancer who experienced disease progression on or after systemic treatment.

Based on results from the phase 3 QUILT-3.032 trial, the FDA has approved nogapendekin alfa inbakicept for patients with Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer.

Based on results from the phase 3 ALINA trial, the FDA has approved alectinib in the adjuvant setting for patients with resected ALK-positive non-small cell lung cancer.

The FDA granted accelerated approval to lisocabtagene maraleucel for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least 2 prior lines of therapy, including a BTK...