publication date: Oct. 25, 2019

Drugs & Targets

FDA approves indication for Zejula in advanced ovarian, fallopian tube, or primary peritoneal cancer

FDA approved GlaxoSmithKline’s Zejula (niraparib) for treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer.

The indication is approved in patients who have been treated with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency positive status defined by either:

A deleterious or suspected deleterious BRCA mutation, or

genomic instability and who have progressed more than six months after response to the last platinum-based chemotherapy.

Patient selection is based on an FDA-approved companion diagnostic for Zejula.

This approval marks the first time the FDA has approved a poly (ADP-ribose) polymerase inhibitor for use in patients beyond those with a BRCA-positive mutation as monotherapy in the late-line treatment setting. Now women with late line, HRD-positive disease are eligible to be treated with a PARP inhibitor. This new indication is based on QUADRA, the largest completed clinical trial evaluating the activity of a PARP inhibitor in women who received three or more treatments for advanced ovarian cancer. QUADRA represents a real-world, difficult-to-treat patient population with high unmet needs.

Zejula received initial FDA approval in March 2017 as a maintenance treatment for women with recurrent ovarian cancer who achieved a response to platinum-based chemotherapy and remains the only once-daily oral PARP inhibitor.

 

FDA approves test to identify patients eligible for treatment with Zejula in late-line Ovarian Cancer

FDA approved myChoice CDx for use as a companion diagnostic to identify women with advanced ovarian cancer who are candidates for Zejula (niraparib) in the late-line treatment setting.

Myriad Genetics sponsors the … Continue reading FDA approves indication for Zejula in advanced ovarian, fallopian tube, or primary peritoneal cancer

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