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Talazoparib FDA approved for deleterious germline BRCA-mutated HER2‑negative breast cancer
By: News Feed | Last updated: 18th October 2018 | In: Breast Cancer, Oncology, Targeted Therapies, US FDA Onc\Haem Approvals
BMN-673, BRACAnalysis, BRCA, CDx, FDA, gBRCAm, germline BRCA-mutated, Myriad Genetics, PARP, PARPi, Pfizer, talazoparib, Talzenna
On October 16, 2018, the FDA approved poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna®, Pfizer) for use in patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) locally advanced or metastatic human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Patients should be selected for the PARP inhibitor (PARPi)-treatment using the FDA-approved companion diagnostic (CDx) for talazoparib.
The Phase III, open‑label, parallel-arm, multi-centre EMBRACA (NCT01945775) study randomised 431 patients with gBRCAm HER2‑negative locally advanced or metastatic breast cancer in a 2:1 fashion to either receive talazoparib (1 mg) or physician’s choice chemotherapy (i.e. capecitabine, eribulin, gemcitabine, or vinorelbine). All participants had a known or suspected deleterious gBRCA mutation and received ≤3 lines of prior cytotoxic systemic therapies for locally advanced or metastatic disease. All patients had received prior treatment with an anthracycline and/or a taxane —unless contraindicated— in the (neo)adjuvant and/or metastatic treatment setting. The primary efficacy endpoint was progression-free survival (PFS) by blinded independent central review (BIRC) according to RECIST1.1.
The most common (≥20%) adverse reactions of any Grade were fatigue, anaemia, nausea, neutropenia, headache, thrombocytopenia, vomiting, alopecia, diarrhoea, and decreased appetite. The FDA approved prescribing information contains warnings and precautions for myelodysplastic syndrome/acute myeloid leukaemia, myelosuppression, and embryo-foetal toxicity.
Together with the approval of talazoparib, the FDA approved the BRACAnalysis CDx test (Myriad Genetic Laboratories, Inc.) to identify (suspected) deleterious gBRCAm and to select breast cancer patients eligible for talazoparib-treatment. The BRACAnalysis CDx test was validated in the EMBRACA trial population.
This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).
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