Weekly Top News – Breast Cancer – June 24, 2019

June 24, 2019

docetaxel / generics; carboplatin / generics
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer (clinicaltrials.gov) – Jun 18, 2019 – P3; N=580; Recruiting; Sponsor: Shanghai Institute Of Biological Products


[fam-] trastuzumab deruxtecan (DS-8201) / Daiichi Sankyo
DS-8201 China launch estimate: By 2021 (Deutsche Bank Research) – Jun 21, 2019 – A subscription to Thomson ONE is required to gain full access to report 67458052; Page no: 1; REPORT TITLE: “China watch P322: Takeaways from ASCO – Pyrotinib, enjoy while you can”; AUTHOR: Hu, Jack, et al; DATE: 06/06/2019


Talzenna (talazoparib) / Pfizer
European Commission approves Talzenna (talazoparib) for patients with inherited (germline) BRCA-mutated locally advanced or metastatic breast cancer (Businesswire) – Jun 21, 2019 – “Pfizer Inc…today announced that the European Commission approved TALZENNA®(talazoparib)…as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy…The European Commission’s approval of TALZENNA…is based on results from the EMBRACA trial…”


Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from KEYNOTE-242 trial for adjuvant TNBC in 2026 or later (Merck (MSD)) – Jun 21, 2019 – Investor Day: Data from P3 KEYNOTE-630 trial (NCT03833167) for high-risk locally advanced cutaneous squamous cell carcinoma in 2026 or later


Keytruda (pembrolizumab) / Merck (MSD)
Keytruda: Data from P3 KEYNOTE-412 trial (NCT03040999) for locally advanced HNSCC in 2023 (Merck (MSD)) – Jun 21, 2019 – Investor Day: Data from P3 KEYNOTE-756 trial (NCT03725059) for ER+/HER2- breast cancer in 2026 or later


HLX02 (trastuzumab biosimilar) / Fosun Pharma
European Medicines Agency accepted first “China-developed” biosimilar – Henlius HLX02 Marketing Authorization Application for review (PRNewswire) – Jun 21, 2019 – “Henlius…announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02….HLX02 is indicated for human epidermal growth factor receptor 2-positive (HER2+) early-stage breast cancer, HER2+ metastatic breast cancer, and untreated HER2+ metastatic gastric and gastroesophageal junction (GEJ) cancer.”


Halaven (eribulin mesylate) / Eisai
Eisai’s breast cancer treatment Halaven enters Peru (GBI Health) – Jun 20, 2019 – “Uruguay-based Biotoscana this week obtained clearance from Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) to market Japan-based Eisai’s microtubule inhibitor Halaven (eribulin mesylate), GBI analysis reveals. While the agency does not disclose approved indications, the drug is developed as a treatment for metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens.”


Rozlytrek (entrectinib) / Roche
Japan becomes the first country to approve Roche’s personalised medicine Rozlytrek (Roche Press Release) – Jun 18, 2019 – “Roche…announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Rozlytrek® (entrectinib) for the treatment of adult and paediatric patients with neurotrophic tyrosine receptor kinase (NTRK) fusion-positive, advanced recurrent solid tumours…Rozlytrek is also undergoing regulatory review in Japan for the treatment of people with ROS1 fusion-positive locally advanced or metastatic non-small cell lung cancer….The data package for this first approval of Rozlytrek includes the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, as well as data from the Phase I/II STARTRK-NG study in paediatric patients.”


Verzenio (abemaciclib) / Eli Lilly
proMONARCH: A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer (clinicaltrials.gov) – Jun 17, 2019 – P4; N=650; Not yet recruiting; Sponsor: Eli Lilly and Company


ORIN1001 / Fosun Pharma
Breast cancer drug gets FDA’s fast-track treatment (China Daily) – Jun 17, 2019 – “Shanghai Fosun Pharmaceutical Group Co Ltd announced on Sunday its experimental drug ORIN1001 has received fast-track designation from the US Food and Drug Administration for the treatment of patients with relapsed, refractory and metastatic breast cancer, including triple-negative breast cancer, or TNBC.”

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