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Verzenio (abemaciclib) / Eli LillyVerzenio: Data from P3 MONARCH-2 trial (NCT02107703) in HER2- breast cancer at ESMO (September 27 - October 1, 2019) (Eli Lilly) - Sep 10, 2019 - World Lung: Data from P2 monarcHER trial (NCT02675231) in metastatic breast cancer at ESMO (September 27 - October 1, 2019) [Screenshot][fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZenecaDaiichi Sankyo advances [fam-] trastuzumab deruxtecan (DS-8201) in Japan with regulatory submission in HER2 positive metastatic breast cancer (Daiichi Sankyo Press Release) - Sep 9, 2019 - "Daiichi Sankyo Company...today announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour and Welfare (MHLW) for the use of [fam-] trastuzumab deruxtecan (DS-8201), an investigational HER2 targeting antibody drug conjugate (ADC), for the treatment of patients with HER2 positive metastatic breast cancer...'We are proud to initiate this critical next step in the regulatory process in Japan and look forward to the presentation of the phase 2 DESTINY-Breast01 study of [fam-] trastuzumab deruxtecan to the scientific community,' said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo."Ibrance (palbociclib) / Pfizer; Kisqali (ribociclib) / Novartis; Verzenio (abemaciclib) / Eli LillyFDA warns against pneumonitis with CDK 4/6 inhibitor drugs for breast cancer (Korea Biomedical Review) - Sep 16, 2019 - "The U.S. Food and Drug Administration added a warning that the entire class of cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor drugs for breast cancer could cause pneumonitis. However, the regulator made it clear that the medicines’ overall benefit was still greater than the risks for advanced breast cancer patients. The FDA said on Friday that Pfizer’s Ibrance (ingredient: palbociclib), Novartis’ Kisqali (ribociclib), and Lilly’s Verzenio (abemaciclib) might cause rare but severe lung inflammation in patients with advanced breast cancer."Nerlynx (neratinib) / PumaPuma Biotechnology announces U.S. FDA acceptance of Supplemental New Drug Application for neratinib to treat HER2-positive metastatic breast cancer (Businesswire) - Sep 11, 2019 - “Puma Biotechnology, Inc….announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib in combination with capecitabine for the treatment of patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy (third-line disease)….The FDA confirmed that the review will have an action date of late April, 2020….The sNDA is supported by the results of the Phase III NALA trial…”Herzuma (trastuzumab biosimilar) / Nippon Kayaku, Pfizer, Mundipharma, Celltrion, TevaCanada OKs Celltrion's biosimilar (Korea Biomedical Review) - Sep 10, 2019 - "Celltrion said that Health Canada has given the go-ahead for Herzuma (Ingredient: Trastuzumab), an anticancer antibody biosimilar, in treating breast and gastric cancer."Piqray (alpelisib) / NovartisNovartis’s kinase inhibitor Piqray makes its way into Latin America (GBI Health) - Sep 11, 2019 - "The National Health Surveillance Agency (ANVISA) this week granted Brazil market clearance to Switzerland-based Novartis’s oncology treatment Piqray (alpelisib), as GBI analysis reveals. The oral drug is developed to treat hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer. However, the agency is yet to publish indication details."Lynparza (olaparib) / Merck (MSD), AstraZeneca; Keytruda (pembrolizumab) / Merck (MSD)Pivotal new data from Merck’s broad oncology portfolio at ESMO 2019 Congress (Merck (MSD) Press Release) - Sep 9, 2019 - "Merck...announced new data from its broadoncology portfolio and pipeline will be presented at the European Society for Medical Oncology (ESMO) 2019 Congress in Barcelona, Spain, from Sept. 27-Oct. 1, 2019. More than 80 abstracts involving Merck cancer medicines and investigational candidates will be featured at the congress, spanning over 18 tumor types. Three of these abstracts – KEYTRUDA data in triple-negative breast cancer (TNBC), LYNPARZA data in prostate cancer and LYNPARZA data in ovarian cancer – were selected for inclusion in the ESMO Presidential Symposium sessions."Keytruda (pembrolizumab) / Merck (MSD); Bria-IMT (SV-BR-1-GM) / BriaCellBriaCell to present September 19th at 2nd Annual Next Gen Immuno-Oncology Congress in Philadelphia (GlobeNewswire) - Sep 16, 2019 - P1/2, N=40; NCT03328026; Sponsor: BriaCell Therapeutics Corporation; “BriaCell Therapeutics Corp….announces that the Company will be presenting at the 2nd Annual Next Gen Immuno-Oncology Congress, taking place September 19-20, 2019 at Hilton Garden Inn, Philadelphia Center City….present the latest clinical findings of the Phase I/IIa clinical trial of Bria-IMT™, BriaCell’s lead candidate, in a Combination Study with pembrolizumab…”leronlimab (PRO 140) / CytoDynCytoDyn Announces FDA Clearance to Proceed with Phase 2 Study of Leronlimab (PRO 140) and Regorafenib as a Combination Therapy for Metastatic Colorectal Cancer (GlobeNewswire, CytoDyn Inc.) - Sep 9, 2019 - "CytoDyn Inc...announced today that the FDA has allowed a Phase 2 study to proceed for combination therapy of leronlimab and Regorafenib in patients with metastatic colorectal cancer (mCRC). The study will be conducted by lead principal investigator, John L. Marshall, M.D., Director, The Ruesch Center for the Cure of GI Cancers Frederick P. Smith Endowed Chair, Chief, Hematology and Oncology Lombardi Comprehensive Cancer Center, Georgetown University Medical Center, Washington, D.C. “We have completed our safety review of your application and have concluded that you may proceed with your proposed clinical investigation of Protocol number CD08_mCRC, entitled, “A Phase II Study of Leronlimab (PRO 140) in combination with Regorafenib..."Tecentriq (atezolizumab) / RocheTecentriq sales projection: Consensus of $4.2B in 2023 and $4.8B peak (Morgan Stanley) - Sep 13, 2019 - A subscription to Thomson ONE is required to gain full access to report 67912369; Page no: 7; REPORT TITLE: "Pharmaceuticals: Specialist prescribing dynamics: Focus on oncology”; AUTHOR: Purcell, Mark, et al; DATE: 09/05/2019Imfinzi (durvalumab) / AstraZeneca, CelgeneImfinzi sales projection: $3.8B peak (J.P. Morgan) - Sep 14, 2019 - A subscription to Thomson ONE is required to gain full access to report 67911951; Page no: 29; REPORT TITLE: "European Pharma & Biotech: back to school: We still prefer the large ones: Overweight Novo, Astra & Roche”; AUTHOR: Vosser, Richard, et al; DATE: 09/04/2019
