This article is more than 5 years old. Information may no longer be current.

FDA approves Talzenna for BRCA-mutated, HER2-negative breast cancer

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

The FDA approved talazoparib — a poly (ADP-ribose) polymerase inhibitor — for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2negative locally advanced or metastatic breast cancer.

Patients must be selected for therapy using a companion diagnostic.

The FDA also approved the BRACAnalysis CDx test (Myriad Genetic Laboratories) to identify patients eligible for talazoparib (Talzenna, Pfizer).

The FDA based approval of talazoparib on the randomized, open-label EMBRACA trial involving 431 patients with deleterious or suspected deleterious germline BRCA-mutated, HER2negative breast cancer. All patients received no more than three prior cytotoxic chemotherapy regimens for locally advanced or metastatic disease. Patients were required to have received treatment with an anthracycline and/or a taxane (unless contraindicated) in the neoadjuvant, adjuvant and/or metastatic treatment setting.

Researchers randomly assigned patients 2:1 to 1 mg talazoparib or physician’s choice of chemotherapy (capecitabine, eribulin [Halaven, Eisai], gemcitabine or vinorelbine).

PFS assessed by blinded independent review with RECIST 1.1 criteria served as the primary endpoint.

Researchers observed a median PFS of 8.6 months among those receiving talazoparib compared with 5.6 months among those receiving chemotherapy (HR = 0.54; 95% CI, 0.41-0.71).

The FDA used data from the EMBRACA trial population to approve the BRACAnalysis CDx test.

The prescribing information for talazoparib includes warnings and precautions for myelodysplastic syndrome/acute myeloid leukemia, myelosuppression and embryo-fetal toxicity. Most common adverse reactions of any grade included fatigue, anemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhea and decreased appetite.