HER2 negative

  •   Emma Shtivelman, PhD

    Excerpt:

    “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.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.

  •   Emma Shtivelman, PhD

    Excerpt from Healio:

    “A trial assessing the alpha-specific PI3K inhibitor alpelisib with fulvestrant met its primary endpoint of PFS among patients with hormone receptor-positive, HER-2-negative advanced breast cancer with a PIK3CA mutation, according to the agent’s manufacturer.

    “Alpelisib (BYL719, Novartis) is an inhibitor of the PI3K pathway. About 40% of patients with hormone receptor-positive breast cancer harbor PIK3CA mutations.

    “The phase 3 global, double-blind SOLAR-1 study included 572 women and men with PIK3CA-mutated hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer that progressed on or following prior aromatase inhibitor treatment with or without a CDK4/6 inhibitor.”

    Go to full article published by Healio on Aug 24, 2018.

    If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to get support from Cancer Commons.