Under the supplemental new drug application (sNDA) submitted to the regulator, Tesaro is seeking approval of niraparib for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer in patients who were previously subjected to three or more prior chemotherapy regimens.
More specifically, the approval for the PARP inhibitor is being sought for such patients whose cancer is associated with either BRCA mutation or homologous recombination deficiency (HRD) with their condition progressed more than six months following the last platinum-based chemotherapy.
The FDA has given an action date of 24 October 2019 for its decision on the PARP inhibitor. The sNDA for niraparib is supported by data from the phase 2 QUADRA trial.
In the mid-stage trial, the drug showed activity in the primary efficacy population of fourth and fifth-line HRD positive patients who were PARP inhibitor naïve, and platinum sensitive. The objective response rate (ORR) was 29%, while the duration of response (DOR) was 9.2 months.
In patients, who were fourth line or greater with BRCA mutations, including platinum-sensitive, resistant and refractory, the ORR was 31%, while the median DOR was 9.4 months.
Tesaro president and chief operating officer Mary Lynne Hedley said: “The results of the QUADRA study demonstrate that ZEJULA is active as a late-line treatment for patients beyond those with BRCA mutations. With this study, we continue to advance our mission to provide more patients with ovarian cancer an opportunity to benefit from treatment with ZEJULA.”
Zejula has approvals in the US and Europe as a treatment for recurrent ovarian cancer in adult patients who respond to platinum-based chemotherapy, irrespective of BRCA mutation or biomarker status.
The ongoing development programme for the PARP inhibitor includes a phase 3 trial called PRIMA in first-line ovarian cancer, a phase 3 trial called BRAVO in germline BRCA-mutated, metastatic breast cancer and the QUADRA trial.
Earlier this year, GSK completed its £4bn acquisition of Tesaro, which is a US-based oncology-focused biopharma company.