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The FDA approval was for germline BRCA mutated (gBRCAm) advanced ovarian cancer that has received three or more prior lines of chemotherapy. [7] In January 2018, olaparib became the first PARP inhibitor to be approved by the FDA for gBRCAm metastatic breast cancer.
The FDA had given accelerated approval for Elahere in Nov. 2022, based on data from a single-arm trial in patients who had received at least one prior line of therapy that included Swiss-based ...
In April 2018 it was granted FDA approval. Niraparib: In March 2017 approved by US FDA for epithelial ovarian, fallopian tube, and primary peritoneal cancer. [9] [10] Inhibitor of PARP1 and PARP2. [11] Talazoparib was approved in 2018 by US FDA for breast cancer with germline BRCA mutations. [12]
Durvalumab, [8] sold under the brand name Imfinzi, is an FDA-approved immunotherapy for cancer, developed by Medimmune/AstraZeneca. [9] It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that blocks the interaction of programmed cell death ligand 1 with the PD-1 (CD279).
T cells are a type of cell that helps the immune system fight cancer and infections. [3] Lifileucel is the first tumor-derived T cell immunotherapy approved by the US Food and Drug Administration (FDA). [3] It was approved for medical use in the United States in February 2024. [2] [4]
Mirvetuximab soravtansine, sold under the brand name Elahere, is a medication used as a treatment for epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. [ 2 ] [ 5 ] Mirvetuximab soravtansine is a folate receptor alpha directed antibody and microtubule inhibitor conjugate.
It was approved in 2014. Nivolumab is approved to treat melanoma, lung cancer, kidney cancer, bladder cancer, head and neck cancer, and Hodgkin's lymphoma. [159] A 2016 clinical trial for non-small cell lung cancer failed to meet its primary endpoint for treatment in the first-line setting, but is FDA-approved in subsequent lines of therapy. [160]
Tarlatamab, sold under the brand name Imdelltra, is an anti-cancer medication used for the treatment of extensive-stage small cell lung cancer. [17] It is a bispecific T-cell engager that binds delta-like ligand 3 and CD3. [17]