US FDA Gives Green Light to GSK’s Zejula for Ovarian Cancer
The U.S. Food and Drug Administration (FDA) Wednesday cleared the expanded use of GlaxoSmithKline Plc’s Zejula as a first option to keep superior ovarian cancer at bay in women who’ve responded to chemotherapy.
The approval, which does not cap the drug to women with certain genetic anomalies, ought to open up Zejula to expanded use in a larger patient population and will signal a similar alternative for the different medication in the same class, known as PARP inhibitors.
PARP inhibitors work by stopping enzymes involved in repairing broken DNA, thereby helping to remove cancer cells. They are a growing focus for drug t, with testing e potential to be used in breast, lung, and prostate cancers.
Zejula is the first PARP inhibitor cleared for use by itself as a first-line maintenance remedy for ovarian cancer sufferers who do not have a mutation of the BRCA enzyme, which happens in about 20% of women with ovarian cancer.
Maintenance therapy – that means it’s used to keep cancer from recurring – can significantly increase sales as a result of the drug is typically used for an extended period.
The FDA nod will help Zejula better compete with rival PARP inhibitors, which include AstraZeneca and Merck & Co’s Lynparza and Clovis Oncology’s Rubraca.
Zejula was beforehand approved to be used as a maintenance remedy in patients who had recurrent bouts of ovarian most cancers and as a treatment for sufferers with specific genetic mutations who had previously been given a number of rounds of chemotherapy.