GSK PLC (LSE:GSK, NYSE:GSK) said the second-line applications of its cancer drug will be limited in scope.
The front-line use of Zejula, which has been developed to treat epithelial ovarian, fallopian tube, or primary peritoneal cancers, remains unchanged.
It will be given to people who have seen a complete or partial response to platinum-based chemotherapy.
However, the US Food and Drug Administration (FDA) requested the alteration to the second-line deployment of the product.
From here on in it will be given to a very limited cohort of people. Specifically, it will be those with deleterious or suspected deleterious germline BRCA mutations of the disease.
The change in guidance follows the FDA’s analysis of overall survival data from a phase III evaluation of Zejula.