talazoparib
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November 20, 2018
FDA Approves Talazoparib for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer Bookmark
Emma Shtivelman, PhDExcerpt:
“On October 16, 2018, the Food and Drug Administration approved talazoparib (TALZENNA, Pfizer Inc.), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2‑negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on an FDA-approved companion diagnostic for talazoparib.
“Approval was based on EMBRACA (NCT01945775), an open‑label trial randomizing 431 patients (2:1) with gBRCAm HER2‑negative locally advanced or metastatic breast cancer to receive talazoparib (1 mg) or physician’s choice of chemotherapy (capecitabine, eribulin, gemcitabine, or vinorelbine). All patients were required to have a known deleterious or suspected deleterious gBRCA mutation and must have received no more than 3 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.”
Go to full article published by the U.S. Food and Drug Administration on Oct 16, 2018.
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August 22, 2018
PARP Inhibitor Talazoparib Benefit in BCRA+ Breast Cancer Bookmark
Emma Shtivelman, PhDExcerpt from Medscape:
“The now-published results from the EMBRACA study confirm that talazoparib (Pfizer), a poly-adenosine diphosphate-ribose polymerase (PARP) inhibitor, prolongs progression-free survival (PFS) in patients with advanced BCRA-positive breast cancer compared with single-agent chemotherapy alone, and that it also significantly improves quality of life.
” ‘This is the largest randomized trial in BRCA mutation carriers [ever undertaken] and demonstrates PARP efficacy,’ Jennifer Litton, MD, associate professor in the Department of Breast Medical Oncology, University of Texas MD Anderson Cancer Center, Houston, told Medscape Medical News in an email.”
Go to full article published by Medscape on Aug 15, 2018.
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