FDA Approves Drug to Treat HER2-negative Breast Cancer with Germline BRCA Mutations

The U.S. Food and Drug Administration (FDA) has granted approval of talazoparib to treat adult patients with HER2-negative locally advanced or metastatic breast cancer with germline BRCA (gBRCA) mutations. 

Talazoparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is marketed as Talzenna and distributed by Pfizer Inc. 

The decision follows the Phase 3 EMBRACA trial, an open-label, randomized study that compared talazoparib with chemotherapy in gBRCA locally advanced and/or metastatic breast cancer patients who have received no more than three previous chemotherapy regimens for advanced disease (n = 431). At a median 11.2 months follow-up, median progression-free survival in the talazoparib group was 8.6 months (95% CI, 7.2-9.3) compared to 5.6 months (95% CI, 4.2-6.7) in the chemotherapy group (HR, 0.54; 95% CI: 0.41-0.71; P < 0.0001). 

.@JenniferLitton on EMBRACA clinical trial: "The results are quite exciting and indicate talazoparib is a novel treatment option for patients with metastatic #breastcancer and #BRCA mutations.” https://t.co/HJb2Iw65iX #BCSM #endcancer

— MD Anderson Cancer Center (@MDAndersonNews) August 16, 2018

BREAKING: Dr. Yardley Discusses the @US_FDA Approval of Talazoparib in Breast Cancer #bcsm https://t.co/gRJpTdYJp5

— OncLive.com (@OncLive) October 16, 2018

The FDA also approved the BRACAnalysis CDx test, a diagnostic companion that identifies patients with breast cancer with deleterious or suspected deleterious gBRCA mutations who are talazoparib candidates. The BRACAnalysis CDx test’s effectiveness was used during the EBRACA trial to determine if deleterious or suspected deleterious gBRCA mutations were present with either prospective or retrospective testing using the BRACAnalysis CDx test. The BRACAnalysis CDx test is manufactured by Myriad Genetic Laboratories, Inc. 

#CancerAnswersFromClinicalTrials Talazoparib is a NON-CHEMO PILL very well tolerated! Dr Litton also tested Talazoparib for 6 months BEFORE surgery in pts w BRCA mutations who were just diagnosed. In over 50% of pts, the tumor totally disappeared! https://t.co/XwTPqR2xRq Hi 5! pic.twitter.com/uM5u61DMz7

— Frankie Ann Holmes MD FACP (@BreastCaDoc_FAH) October 16, 2018

Talazoparib is to be taken in a once-daily single dose of 1 mg. The most common adverse effects associated with the drug were fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea, and decreased appetite. 

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FDA approves talazoparib for gBRCAm HER2-negative locally advanced or metastatic #breastcancer – #bcsm -Approval Info: https://t.co/kVHYYBeonL Drug label: https://t.co/a6PFnKoJfh

— FDA Oncology (@FDAOncology) October 16, 2018

Based on EMBRACA results FDA approves talazoparib for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) HER2-negative breast cancer. FDA also approved the BRACAnalysis CDx® test (Myriad) to identify patients with gBRCAm https://t.co/ZAyn5vnZHT

— Antonio Giordano, MD PhD (@antgiorda) October 16, 2018

Sources: FDA, OncLive