FDA approves Hengrui Medicine's PARP inhibitor international multi-center Phase 3 clinical trial for prostate cancer

Source: Guanlan Pharmaceutical

Recently, Hengrui Medicine announced that its PARP inhibitor fluzoparib capsules have been approved by the US FDA to conduct an international multi-center phase 3 clinical trial to evaluate fluzoparib capsules combined with abiraterone acetate tablets and prednisone tablets.

PARP (Polyadenosine Diphosphate Ribose Polymerase) is an important DNA repair protein in cells, mainly repairing DNA double-strand damage.

Prostate cancer is one of the common cancers among men in the world.

Fluzoparib is a PARP inhibitor independently developed by Hengrui Medicine, which can inhibit the DNA repair process in BRCA1/2 dysfunctional cells, induce cell cycle arrest, and then inhibit tumor cell proliferation.

According to the press release, the FDA approved a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical study to evaluate fluzoparib capsules combined with abiraterone acetate tablets and prednisone tablets ( AA-P) Compare the effect of placebo combined with AA-P in the first-line treatment of patients with metastatic castration-resistant prostate cancer.

According to the Chinese drug clinical trial registration and information disclosure platform, Hengrui Medicine has registered more than 30 clinical trials on fluzoparib monotherapy or combination therapy.