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Tecentriq (atezolizumab) / RocheTecentriq: Data from P3 IMpassion031 trial (NCT03197935) for neoadjuvant TNBC in H1 2020 (Roche) - Dec 17, 2019 - SABCS 2019 [Screenshot]margetuximab (MGAH 22) / MacroGenicsFDA approval sought for margetuximab in HER2+ metastatic breast cancer (OncLive) - Dec 20, 2019 - "MacroGenics, Inc. has submitted a biologics license application (BLA) for margetuximab for use in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer....'Margetuximab’s Fc engineering enhances both innate and adaptive immunity, creating a coordinated engagement of HER2-targeted immunity,' added Rugo."Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZenecaEnhertu (trastuzumab deruxtecan) approved in the US for HER2-positive unresectable or metastatic breast cancer following two or more prior anti-HER2 based regimens (AstraZeneca Press Release) - Dec 20, 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 patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. This indication is approved under Accelerated Approval based on tumour response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial...the FDA approval is based on the results of the registrational Phase II trial DESTINY-Breast01..."margetuximab (MGAH 22) / MacroGenicsMacroGenics announces submission of margetuximab Biologics License Application to U.S. FDA (GlobeNewswire) - Dec 19, 2019 - “MacroGenics, Inc…announced that the Company has submitted a Biologics License Application (BLA) for margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2. The margetuximab BLA is for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy. The submission is based on the safety and efficacy results of the pivotal phase 3 SOPHIA study…”Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZenecaDS-8201: “Median time to response was 1.6 months (95% CI, 1.4-2.6 months)”; Breast cancer (Daiichi Sankyo) - Dec 18, 2019 - R&D Day 2019: "Confirmed ORR: 60.9%a (95% CI, 53.4%–68.0%) 11 CRs" [Screenshot]Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZenecaDS-8201: Data presentation from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer at ASCO (May 29- June 02, 2020) (Daiichi Sankyo) - Dec 18, 2019 - Data presentation from P2 DESTINY-Gastric01 trial (NCT03329690) for HER2-overexpressing advanced gastric cancer at ASCO (May 29- June 02, 2020) [Screenshot]Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; Tecentriq (atezolizumab) / RocheEL1SSAR: A Study of Atezolizumab (Tecentriq) Plus Nab-Paclitaxel or Paclitaxel in the Treatment of Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov) - Dec 18, 2019 - P3; N=280; Recruiting; Sponsor: Hoffmann-La Roche; Not yet recruiting --> RecruitingKadcyla (ado-trastuzumab emtansine) / RocheEuropean Commission approves Roche’s Kadcyla for the adjuvant treatment of people with HER2-positive early breast cancer with residual invasive disease after neoadjuvant treatment (Roche Press Release) - Dec 19, 2019 - "Roche...announced that the European Commission has approved Kadcyla® (trastuzumab emtansine) for the adjuvant (after surgery) treatment of adult patients with HER2-positive early breast cancer (eBC) who have residual invasive disease in the breast and/or lymph nodes after neoadjuvant (before surgery) taxane-based and HER2-targeted therapy...The approval of Kadcyla in Europe is based on results from the phase III KATHERINE study, which showed that Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50%..."tucatinib (ARRY-380) / Seattle Genetics; Herceptin (trastuzumab) / Roche; capecitabine / Generic mfg.Seattle Genetics announces U.S. FDA grants Breakthrough Therapy Designation for tucatinib in locally advanced or metastatic HER2-positive breast cancer (Businesswire) - Dec 18, 2019 - "Seattle Genetics, Inc...announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to tucatinib, in combination with trastuzumab and capecitabine, for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have been treated with trastuzumab, pertuzumab, and T-DM1...'We intend to submit a New Drug Application to the FDA and an MAA to the EMA by the first quarter 2020'...This Breakthrough Therapy designation was based on data from the pivotal HER2CLIMB clinical trial..."tucatinib (ARRY-380) / Seattle GeneticsSeattle Genetics announces submission of tucatinib New Drug Application to the U.S. FDA for patients with locally advanced or metastatic HER2-positive breast cancer (Businesswire) - Dec 23, 2019 - "Seattle Genetics, Inc...announced it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tucatinib. This NDA requests FDA approval of tucatinib in combination with trastuzumab and capecitabine for treatment of patients with locally advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received at least three prior HER2-directed agents separately or in combination, in the neoadjuvant, adjuvant or metastatic setting. The submission is based on the results of HER2CLIMB, a randomized pivotal trial..."
