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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 cohort used for the approved indication was conducted at 40 sites in 7 countries in North America and Europe. [37] In 2022, an early clinical study of dostarlimab reported a 100% remission rate in 14 patients with rectal cancer who had mismatch repair deficiency, a type of genetic mutation that only affects 5-10% of cases. [38] [39] [40]
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]
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 ...
Mirvetuximab soravtansine is indicated for the treatment of adults with folate receptor alpha (FRα) positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. [2] [5] [6] Recipients are selected for therapy based on an FDA ...
NDA submitted Jun 2016, [19] and the FDA should decide by 30 June 2017. [20] In April 2016, it was reported that the phase III trial for low-grade ovarian cancer was terminated due to lack of efficacy. [21] In 2017, the FDA informed Array Biopharma that the phase III trial data was not sufficient and the New Drug Application was withdrawn. [22]
The US Food and Drug Administration (FDA) approved it in March 2017, for the treatment of Merkel-cell carcinoma, [84] an aggressive type of skin cancer. The EMA approved it in September 2017, for the same indication. [86] This is the first FDA-approved treatment for metastatic Merkel-cell carcinoma, a rare, aggressive form of skin cancer. [84]
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
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