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US FDA grants priority review designation for Tesaro's Zejula.

M2 EQUITYBITES-June 26, 2019-US FDA grants priority review designation for Tesaro's Zejula


The United States Food and Drug Administration (FDA) has granted priority review designation for United States-based Tesaro's (PARP) polymerase inhibitor Zejula (niraparib) intended for the treatment of late stage ovarian cancer, it was reported yesterday.

According to the supplemental new drug application (sNDA) submitted to the regulator, the company is seeking approval of the product for the treatment of advanced ovarian, fallopian tube, or primary peritoneal cancer in patients who were earlier subjected to three or more prior chemotherapy regimens. More specifically, the approval for the polymerase 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.

In the mid-stage trial, the drug indicated activity in the primary efficacy population of fourth and fifth-line HRD positive patients who were PARP inhibitor naive, 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.'

Tesaro is a GlaxoSmithKline company.

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Publication:M2 EquityBites (EQB)
Date:Jun 26, 2019
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