Tag Archives: Metastatic

FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer

FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer Print this page BOTHELL, Wash.–(BUSINESS WIRE) April 17, 2020 — Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the U.S. Food and Drug Administration (FDA) granted approval to Tukysa™ (tucatinib) tablets in combination with trastuzumab and capecitabine for adult patients with advanced unresectable… Read More »

Lynparza (olaparib) Approved in the US as a First-Line Maintenance Treatment of Germline BRCA-Mutated Metastatic Pancreatic Cancer

Print this page 30 December 2019 — AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) today announced that Lynparza® (olaparib) has been approved in the US for the maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma whose… Read More »

FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens

FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens Print this page 20 December 2019 — AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has approved Enhertu® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult… Read More »

FDA Approves Genentech’s Tecentriq Plus Chemotherapy (Abraxane and Carboplatin) for The Initial Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer

Print this page South San Francisco, CA — December 3, 2019 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq (atezolizumab) in combination with chemotherapy (Abraxane ® [paclitaxel protein-bound; nab-paclitaxel] and carboplatin) for the initial (first-line) treatment of adults… Read More »

FDA Approves Erleada (apalutamide) for the Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

Print this page HORSHAM, Pa., Sept. 17, 2019 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Erleada (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC).1 Today’s approval follows FDA Priority Review Designation of the supplemental New Drug… Read More »