Weekly Top News – Breast Cancer – November 4, 2019

November 4, 2019

[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201 regulatory estimate: Approval in Japan for breast cancer around Jan-Mar 2020 (Morgan Stanley) – Oct 31, 2019 – A subscription to Thomson ONE is required to gain full access to report 68106862; Page no: 1; REPORT TITLE: “Pharmaceuticals: Japan week feedback: Daiichi Sankyo dominated discussion”; AUTHOR: Muraoka, Shinichiro, et al; DATE: 10/15/2019


[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: PDUFA action date for HER2 positive metastatic breast cancer on April 29, 2020 (Daiichi Sankyo) – Nov 1, 2019 – Q2 FY 2019 Results 


Kisqali (ribociclib) / Novartis
Novartis’ breast cancer treatment wins regulator’s nod (Korea Biomedical Review) – Oct 31, 2019 – “Novartis Korea said that the Ministry of Food and Drug Safety has approved Kisqali, a kinase inhibitor, for the treatment of women with advanced or metastatic breast cancer…The ministry approved the drug based on clinical findings demonstrating clinical efficacy, such as the significant prolonged survival rate of Kisqali.”


[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo, AstraZeneca
DS-8201: Data presentation from P2 DESTINY-Breast01 trial (NCT03248492) for (HER2)-positive breast cancer at SABCS (December 11, 2019) (Daiichi Sankyo) – Nov 1, 2019 – Q2 FY 2019 Results 


sacituzumab govitecan (IMMU-132) / Immunomedics
Immunomedics reports third quarter 2019 results and provides corporate update (Immunomedics Press Release) – Oct 30, 2019 – “TROPHY-U-01 reached target enrollment in cisplatin-eligible cohort of 100 patients…’we are on target to submit our Biologics License Application (BLA) for sacituzumab govitecan in late-stage metastatic triple-negative breast cancer (mTNBC) in patients who have received at least two prior therapies for metastatic disease to the FDA in late November or early December, 2019’…In the open-label, Trop-2-enriched multi-cohort Phase 2 TROPiCS-03 study (NCT03964727), the first patient with NSCLC has been dosed.”


capecitabine / Generic Mfg.
EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer (clinicaltrials.gov) – Oct 28, 2019 – P3; N=1384; Completed; Sponsor: Spanish Breast Cancer Research Group; Active, not recruiting –> Completed; Trial completion date: Jan 2019 –> Apr 2019


eftilagimod alpha (IMP 321) / Immutep; Keytruda (pembrolizumab) / Merck (MSD)
Operational update (GlobeNewswire) – Oct 28, 2019 – “Significant eftilagimod alpha clinical data expected in coming months: AIPAC Phase II – data expected in Q1 calendar year 2020; TACTI-002 Phase II – data at SITC in Nov 2019 and in Q1 in 2020; TACTI-mel Phase I – final safety data expected in H1 2020; INSIGHT-004 Phase I – initial safety data expected in Q4 calendar year 2019.”


Zirabev (bevacizumab biosimilar) / Pfizer; Trazimera (trastuzumab biosimilar) / Pfizer
Pfizer announces launch dates for 2 more anticancer biosimilars: Ruxience and Trazimera (Center for Biosimilars) – Oct 29, 2019 – “…Ruxience will become commercially available in January 2020, and Trazimera will follow on February 15, 2020. The company previously confirmed that it plans to launch its biosimilar bevacizumab, Zirabev, on December 31, 2019.”


Lynparza (olaparib) / Merck (MSD), AstraZeneca
AstraZeneca wins expanded indication for anticancer treatment Lynparza (Korea Biomedical Review) – Oct 30, 2019 – “AstraZeneca said that it has received approval from the Ministry of Food and Drug Safety for an additional indication for a new tablet formulation of Lynparza, its poly ADP (adenosine diphosphate)-ribose polymerase (PARP) inhibitor, in treating ovarian and breast cancer. Until now, the Lynparza capsule was the only approved formulation in Korea.”


Ibrance (palbociclib) / Pfizer; Herceptin (trastuzumab) / Roche
PATINA: Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer (clinicaltrials.gov) – Oct 31, 2019 – P3; N=496; Recruiting; Sponsor: Alliance Foundation Trials, LLC.; Trial completion date: Aug 2024 –> Dec 2025; Trial primary completion date: Oct 2020 –> May 2021

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