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Breast Cancer, Metastatic News (Page 4)
Related terms: Metastatic Breast Cancer
FDA Approves Tukysa (tucatinib) for People with Advanced Unresectable or Metastatic HER2-Positive Breast Cancer
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 c...
FDA Approves Enhertu (fam-trastuzumab deruxtecan-nxki) for HER2-Positive Unresectable or Metastatic Breast Cancer Following Two or More Prior Anti-HER2 Based Regimens
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 ...
FDA Approves Trazimera (trastuzumab-qyyp), a Biosimilar to Herceptin
March 11, 2019 - Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Trazimera (trastuzumab-qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the ...
FDA Approves Herzuma (trastuzumab-pkrb), a Biosimilar to Herceptin
INCHEON, South Korea & JERUSALEM--(BUSINESS WIRE) December 14, 2018 --Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. today announced that the U.S. Food and Drug Administration (FDA) has...
FDA Approves Talzenna (talazoparib) for gBRCAm HER2-Negative Locally Advanced or Metastatic Breast Cancer
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...
Lilly Receives Additional FDA Approval for Verzenio (abemaciclib), as Initial Treatment for Advanced Breast Cancer
INDIANAPOLIS, Feb. 26, 2018 /PRNewswire/ – Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved Verzenio (abemaciclib) in combination with...
FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer
January 12, 2018 – The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that...
FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
September 28, 2017 – The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor...
Ibrance (palbociclib) Receives FDA Regular Approval and Expanded Indication for First-Line HR+, HER2- Metastatic Breast Cancer
March 31, 2017 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for its first-in-class cyclin...
FDA Approves Kisqali (ribociclib) for HR+/HER2- Metastatic Breast Cancer
Basel, March 13, 2017 - The US Food and Drug Administration (FDA) has approved Kisqali (ribociclib, formerly known as LEE011) in combination with an aromatase inhibitor as initial endocrine-based...
Pfizer Receives Expanded FDA Approval For Ibrance (palbociclib) In HR+, HER2- Metastatic Breast Cancer
Friday, February 19, 2016 – Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication expanding the use of Ibrance (palbociclib) 125mg...
FDA Approves Ibrance (palbociclib) for Postmenopausal Women with Advanced Breast Cancer
February 3, 2015 – The U.S. Food and Drug Administration today granted accelerated approval to Ibrance (palbociclib) to treat advanced (metastatic) breast cancer. Breast cancer in women is the...
FDA Approves Lymphoseek to Help Locate Lymph Nodes in Patients with Certain Cancers
March 13, 2013 – The U.S. Food and Drug Administration today approved Lymphoseek (technetium Tc 99m tilmanocept) Injection, a radioactive diagnostic imaging agent that helps doctors locate lymph...
FDA Approves Kadcyla for Late-Stage Breast Cancer
February 22, 2013 – The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer. ...
FDA Approves Perjeta (pertuzumab) for People With HER2-Positive Metastatic Breast Cancer
South San Francisco, Calif. – June 8, 2012 – Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has approved Perjeta (pertuzumab). Perjeta is...
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