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Piqray (alpelisib) / NovartisStudy of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation (clinicaltrials.gov) - Dec 23, 2019 - P3; N=548; Not yet recruiting; Sponsor: Novartis Pharmaceuticalssacituzumab govitecan (IMMU-132) / ImmunomedicsImmunomedics announces FDA acceptance for filing of Biologics License Application resubmission for sacituzumab govitecan to treat metastatic triple-negative breast cancer (GlobeNewswire, Immunomedics, Inc.) - Dec 26, 2019 - "Immunomedics, Inc...today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) 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, as a complete class 2 response. The PDUFA target action date of the resubmitted BLA is June 2, 2020."Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZenecaFDA approval of new breast cancer drug offers hope to patients with few options (Boston Herald) - Dec 27, 2019 - "A breast cancer drug that can provide a last resort option to patients who have run out of treatments has been granted accelerated approval from the Food and Drug Administration, a move that could provide a new standard of care for hundreds of thousands of women with the disease. The drug, called Enhertu, was recently granted approval for patients who have received two or more prior treatments for inoperable or metastatic HER2-positive breast cancer, a type of cancer that learns to resist the drugs designed to attack it....'It’s always really hard to know the options are getting thinner. There’s a lot we can do for HER2-positive breast cancer, though we do reach a time where there is little else we have to offer and I think having a drug like this provides a lot of hope,' said Dr. Eric Winer..."Enhertu (fam-trastuzumab deruxtecan-nxki) / Daiichi Sankyo, AstraZenecaDS-8201 regulatory estimate: Approval for 3L+ HER2+ metastatic breast cancer in Q2 2020 (SVB Leerink) - Dec 26, 2019 - A subscription to Thomson ONE is required to gain full access to report 68502825; Page no: 8; REPORT TITLE: "2020 Outlook: Focus on next-generation compounds”; AUTHOR: Berens, Andrew, et al; DATE: 12/16/2019tucatinib (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..."Prescient Therapeutics receives encouraging efficacy results for leading cancer drug candidate PTX-200 (Small Caps) - Dec 23, 2019 - P2a, N=11; "Oncology company Prescient Therapeutics (ASX: PTX) has unveiled news of a high response rate to its PTX-200 leading drug candidate from a phase 2 breast cancer trial....In a statement to the market, Prescient said that it had received 'encouraging efficacy results' in a clinical trial being conducted by Professor Joseph Sparano..."Ibrance (palbociclib) / PfizerIbrance clinical trial estimate: Primary completion of P3 PENELOPE-B trial (NCT01864746) for breast cancer in December 2020 and final completion in November 2023 (Morgan Stanley) - Dec 26, 2019 - A subscription to Thomson ONE is required to gain full access to report 68513174; Page no: 48; REPORT TITLE: "Major Pharmaceuticals: 2020 Outlook: Growth and valuation encouraging”; AUTHOR: Risinger, David, et al; DATE: 12/18/2019Zejula (niraparib) / GSK, ZAI Lab, J&J, Takeda; Keytruda (pembrolizumab) / Merck (MSD)BRCA mutations and homologous recombination repair deficiency in treatment with niraparib combined with pembrolizumab—reply (JAMA Oncology) - Dec 26, 2019 - P1/2, N=121; TOPACIO (NCT02657889); Sponsor: Tesaro, Inc; "We thank Lin and colleagues for their comments and interest in the TOPACIO/KEYNOTE-162 (Niraparib in Combination With Pembrolizumab in Patients With Triple-Negative Breast Cancer or Ovarian Cancer) trial...we found that the ORR was comparable across all ovarian cancer biomarker subpopulations, with efficacy in patients without tBRCA mutations or HRR deficiency. In the TNBC population, the ORRs were higher in patients with tBRCA mutations as expected..."Afinitor (everolimus) / NovartisESR1 Mutations in Asian ER+ Metastatic Breast Cancer on Hormonal Therapy-based Treatments (clinicaltrials.gov) - Dec 27, 2019 - P; N=200; Recruiting; Sponsor: National Taiwan University HospitalImfinzi (durvalumab) / AstraZeneca, BMSImfinzi sales projection: Consensus of $3.5B ($2B (US: >$1B) for advanced NSCLC, $600M for 1L SCLC) by 2024 (Shore Capital) - Dec 26, 2019 - A subscription to Thomson ONE is required to gain full access to report 68483685; Page no: 5; REPORT TITLE: " Shore Capital- Intial morning trading comments 12 December 2019”; AUTHOR: Stockbrokers Black, Clive, et al; DATE: 12/12/2019
