October 23, 2019

The U.S. FDA has approved a new indication for Zejula® (niraparib) oral capsules, manufactured by GlaxoSmithKline. The product is now indicated to treat certain adult patients who have advanced ovarian, fallopian tube, or primary peritoneal cancer. Under the new indication, patients must have been treated with at least three prior chemotherapy regimens, and have a cancer associated with homologous recombination deficiency (HRD) positive status. The patient’s HRD status must be defined by either a deleterious or suspected deleterious BRCA mutation, or by genomic instability. Patients must also have progressed more than six months after response to the last platinum-based chemotherapy.

An estimated 222,000 women in the US have ovarian cancer, which is the leading cause of death by cancers associated with the female reproductive system. Advanced ovarian cancer recurs in approximately 85% of patients. Each recurrence increases the risk of more rapid cancer progression. Patients with advanced ovarian cancer have few treatment options, with less than 10% of patients achieving an overall response when treated with chemotherapy.

In a clinical study, Zejula produced an objective response rate (ORR) of 24%, and a median duration of response (mDOR) of 8.3 months. It is now the first PARP inhibitor to be approved for patients who have late-line, HRD-positive (HRD+) ovarian, fallopian tube, or primary peritoneal cancer. Recommended dosing is 300mg taken once daily with or without food. Treatment should continue until either disease progression or unacceptable adverse reactions occur.

Zejula first received FDA approval in 2017 and is also indicated as a maintenance treatment for adult patients who are currently in complete or partial response to platinum-based chemotherapy and have been diagnosed with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer.

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