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Novel Drug Approvals and New Indications for Gynecologic Cancers


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A number of new drugs and novel indications were added to the treatment armamentarium for gynecologic cancers over the past year. The U.S. Food and Drug Administration (FDA) approvals are noted here.

Olaparib, PARP Inhibitor

On May 8, 2020, the FDA expanded the indication of olaparib (Lynparza) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either a deleterious or suspected deleterious BRCA mutation and/or genomic instability.

Olaparib was approved in December 2018 for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line, platinum-based chemotherapy. The drug received its initial approval from the FDA in August 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.

Niraparib, PARP Inhibitor

On April 29, 2020, the FDA approved niraparib (Zejula) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Earlier, in October 2019, the FDA approved niraparib for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer treated with three or more prior chemotherapy regimens and whose cancer is associated with HRD-positive status. HDR is defined by either a deleterious or suspected deleterious BRCA mutation or genomic instability in patients with disease progression more than 6 months after response to the last platinum-based chemotherapy.

Niraparib was first approved by the FDA in March 2017 for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

Pembrolizumab, PD-1 Antibody

On April 28, 2020, the FDA granted accelerated approval to a new dosing regimen of 400 mg every 6 weeks for pembrolizumab (Keytruda) across all currently approved adult indications, in addition to the current 200 mg every 3 weeks dosing regimen.

In September 2019, the FDA granted accelerated approval to the combination of pembrolizumab plus lenvatinib (Lenvima) for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability–high or mismatch repair–deficient and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation therapy.

In June 2018, pembrolizu-mab received FDA approval for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (Combined Positive Score ≥1) as determined by an FDA-approved test.

Bevacizumab, Angiogenesis Inhibitor

On June 13, 2018, the FDA approved bevacizumab (Avastin) for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV disease after initial surgical resection. 


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