"FDA Approves Olaparib for First-Line Maintenance of BRCA-Mutated, Advanced Ovarian Cancer
On December 19, 2018, the U.S. Food and Drug Administration (FDA) approved the PARP inhibitor olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germ-line 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 FDA also approved BRACA analysis CDx to be used by health-care professionals to identify patients with advanced ovarian cancer who have a germ-line BRCA mutation and are eligible for olaparib following response to platinum-based chemotherapy
Lynparza (olaparib), a poly ADP-ribose polymerase (PARP) inhibitor, co-developed by AstraZeneca and Merck (known as MSD outside the US and Canada), has succeeded in a phase 3 trial (SOLO-3) held in patients with relapsed BRCA-mutated (BRCAm) advanced ovarian cancer by meeting the primary endpoint.
SOLO-3 is the first Phase 3 trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer where effective options are needed".
(The third step in testing an experimental drug (or other treatment) in humans. Phase 3 trials are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials, to compare the drug to standard therapies for the disease or condition being studied, and to evaluate the overall risks and benefits of the drug. This trial phase recruits a large group of people with the disease or condition, usually ranging from 1,000 to 3,000 participants. The Food and Drug Administration (FDA) reviews results from Phase 3 trials when considering a drug for approval.)
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