Talzenna

Treats deleterious or suspected deleterious germline BRCA … metastatic breast cancer. NDA 217439, held by Pfizer. Talazoparib Tosylate.

As of Nov 13, 2026, NDA 217439 (Talzenna), held by Pfizer, was first approved by FDA on Mar 7, 2024, with 2 approved supplements and 0 published complete response letters.

First approved: Mar 7, 2024
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer

As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. HRR Gene-Mutated mCRPC
In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Oct 26, 2026	Supplement 4Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 12, 2025	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Label Letter
Mar 7, 2024	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Letter Label

Products

6 strengths and forms

Product	Active ingredient	Marketing
TalzennaEQ 0.1MG BASE · capsule;oral	Talazoparib Tosylate	RxReference drug
TalzennaEQ 0.25MG BASE · capsule;oral	Talazoparib Tosylate	RxReference drug
TalzennaEQ 0.35MG BASE · capsule;oral	Talazoparib Tosylate	RxReference drug
TalzennaEQ 0.5MG BASE · capsule;oral	Talazoparib Tosylate	RxReference drug
TalzennaEQ 0.75MG BASE · capsule;oral	Talazoparib Tosylate	RxReference drug
TalzennaEQ 1MG BASE · capsule;oral	Talazoparib Tosylate	RxReference drug

Identifiers

Application: NDA 217439
Drugs@FDA: Overview at FDA
Company: Pfizer

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters