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BAT8001 / Bio-Thera SolutionsThe Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer (clinicaltrials.gov) - Dec 4, 2019 - P3; N=410; Active, not recruiting; Sponsor: Bio-Thera SolutionsPiqray (alpelisib) / NovartisAlpelisib: Initiation of P3 trials for HER2+ breast cancer/TNBC/ovarian cancer/head and neck cancer in 2020 (Novartis) - Dec 6, 2019 - R&D Day [Screenshot]Piqray (alpelisib) / NovartisFoundation Medicine expands indication for FoundationOne CDx as a companion diagnostic for Piqray (alpelisib) (Businesswire) - Dec 4, 2019 - “Foundation Medicine, Inc. today announced it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Piqray® (alpelisib) in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen.”Piqray (alpelisib) / NovartisAlpelisib: Regulatory submissions for TNBC/HER2+ advance breast cancer in 2023 (Novartis) - Dec 6, 2019 - R&D Day: Regulatory submission for ovarian cancer in 2023; Regulatory submission for 2L/3L HNSCC in 2024 [Screenshot]Keytruda (pembrolizumab) / Merck (MSD)OncoSec to present interim data from ongoing KEYNOTE-890 study of TAVO and Keytruda in late-stage metastatic triple negative breast cancer at the 2019 San Antonio Breast Cancer Symposium (PRNewswire) - Dec 5, 2019 - "OncoSec Medical Incorporated....announced it will present interim efficacy, immunological and safety data from its ongoing KEYNOTE-890 study of TAVO™ in combination with KEYTRUDA® in patients with late-stage, heavily pretreated, chemo-refractory metastatic triple negative breast cancer (mTNBC) at the upcoming San Antonio Breast Cancer Symposium (SABCS) Annual Meeting being held December 10-14, 2019."Kisqali (ribociclib) / NovartisKisqali: Regulatory submission for HR+, HER2(-) breast cancer (adjuvant) in 2022 (Novartis) - Dec 6, 2019 - R&D Day [Screenshot]Nerlynx (neratinib) / Puma, Knight TherapPuma Biotechnology licensing partner specialised therapeutics receives marketing approval in Singapore for Nerlynx (neratinib) for extended adjuvant treatment of early stage hormone receptor positive HER2-positive breast cancer (Businesswire) - Dec 2, 2019 - "Puma Biotechnology...has received marketing approval of NERLYNX® (neratinib) in Singapore from the Health Sciences Authority (HSA), a statutory board under the Ministry of Health of the Singapore Government. NERLYNX is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy." "Keytruda (pembrolizumab) / Merck (MSD)Biothera Pharmaceuticals phase 2 triple negative breast cancer data selected for Spotlight Session at San Antonio Breast Cancer Symposium (GlobeNewswire) - Dec 4, 2019 - "Biothera Pharmaceuticals, Inc. today announced that response and clinical benefit data from its Phase 2 study of dectin-1 agonist Imprime PGG in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in chemo-refractory metastatic triple negative breast cancer patients have been selected for a poster discussion Spotlight Session on December 11 at the 2019 San Antonio Breast Cancer Symposium."Verzenio (abemaciclib) / Eli LillyEli Lilly stretches 2019 Verzenio approvals streak with Peru nod (GBI Health) - Dec 6, 2019 - "GBI analysis reveals that Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) this week granted Eli Lilly market approval for its kinase inhibitor Verzenio (abemaciclib). The oral therapy is designed to treat hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer, although the agency does not release indication details."sacituzumab govitecan (IMMU-132) / ImmunomedicsImmunomedics resubmits Biologics License Application to the FDA for sacituzumab govitecan (GlobeNewswire) - Dec 3, 2019 - "Immunomedics, Inc...today announced the resubmission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease."
