A5042549540- Lung Cancer Treatments and Mutations
- PARP inhibition in cancer therapy
- BRCA gene mutations in cancer
- Lung Cancer Diagnosis and Treatment
- Cancer Immunotherapy and Biomarkers
- Ovarian cancer diagnosis and treatment
Center for Devices and Radiological Health
2020-2023
United States Food and Drug Administration
2020-2023
Abstract On December 19, 2018, the U.S. Food and Drug Administration (FDA) granted approval to olaparib monotherapy for first-line maintenance treatment of BRCA-mutated (BRCAm) advanced ovarian cancer and, on May 8, 2020, expanded indication include its use in combination with bevacizumab homologous recombination deficient (HRD)–positive cancer. Both these approvals were based randomized, double-blind, placebo-controlled trials. Approval was SOLO-1 trial, comparing efficacy versus placebo...
Abstract The FDA granted accelerated approval for amivantamab-vmjw (hereafter referred to as amivantamab), a bispecific antibody directed against EGFR and mesenchymal–epithelial transition receptor, on May 21, 2021, the treatment of adult patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) exon 20 insertion mutations whose disease has progressed after platinum-based chemotherapy. Approval was based results an ongoing, multicenter, nonrandomized, open-label,...