Pfizer Submits NDA for PARP Inhibitor Talazoparib in China

On April 1, the CDE website showed that Pfizer's Talazoparib Tosylate Capsules marketing application was accepted. This is the fifth PARP inhibitor to be submitted for marketing in China.

Talazoparib, an oral poly ADP-ribose polymerase (PARP) inhibitor acquired by Pfizer in its $14 billion acquisition of Medivation in August 2016, has been shown in studies to inhibit cancer cell growth and promote cancer cell death by inhibiting PARP enzyme activity and trapping PARP at the sites of DNA damage.

In October 2018, talazoparib was first approved for marketing in the United States for the treatment of adult patients with HER2-negative locally advanced or metastatic breast cancer who carry harmful or suspected harmful germline BRCA mutations (gBRCAm), under the trade name Talzenna.

On February 16 this year, Pfizer announced detailed data from the Phase III TALAPRO-2 study of talazoparib combined with enzalutamide for the first-line treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) at the ASCO GU 2023 conference. The results showed that, compared with the placebo group, the radiographic progression-free survival (rPFS) of patients in the talazoparib group was improved both statistically and clinically. Notably, the marketing application for this indication has been granted priority review by the FDA. (See: )

Currently, there are six PARP inhibitors approved globally, among which Olaparib (AstraZeneca), Pamiparib (BeiGene), Niraparib (GSK/Zai Lab), and Fluzoparib (Hengrui) have been approved in China.

Source: PharmaCube NextPharma Database

The PARP inhibitor track is seeing fervent development; apart from those already on the market, there are over 80 PARP inhibitors globally still under research, with most concentrated in the oncology field.

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