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Ibrance (palbociclib) / PfizerNICE backs Ibrance for breast cancer via cancer drugs fund (pharmaphorum) - Nov 28, 2019 - "Pfizer’s Ibrance has been approved for use by the NHS in England as a second-line treatment for advanced breast cancer after hormonal therapy, catching up with rival drugs in the class. The decision by NICE means that CDK4/6 inhibitor Ibrance (palbociclib) will be made available for patients via the Cancer Drugs Fund (CDF), which covers the cost of cancer drugs until confirmatory data is available."Abraxane (albumin-bound paclitaxel) / Otsuka, BMS; Tecentriq (atezolizumab) / RocheAtezolizumab plus nab-paclitaxel as first-line treatment for unresectable, locally advanced or metastatic triple-negative breast cancer (IMpassion130): updated efficacy results from a randomised, double-blind, placebo-controlled, phase 3 trial (Lancet Oncol) - Nov 27, 2019 - P3, N=900; IMpassion130 (NCT02425891); Sponsor: Hoffmann-La Roche; "At the second interim analysis (data cutoff Jan 2, 2019), median follow-up was 18·5 months (IQR 9·6–22·8) in the atezolizumab group and 17·5 months (8·4–22·4) in the placebo group. Median overall survival in the intention-to-treat patients was 21·0 months (95% CI 19·0–22·6) with atezolizumab and 18·7 months (16·9–20·3) with placebo (stratified hazard ratio [HR] 0·86, 95% CI 0·72–1·02, p=0·078). In the exploratory overall survival analysis in patients with PD-L1 immune cell-positive tumours, median overall survival was 25·0 months (95% CI 19·6–30·7) with atezolizumab versus 18·0 months (13·6–20·1) with placebo (stratified HR 0·71, 0·54–0·94])."Tecentriq (atezolizumab) / RocheChugai launches Tecentriq intravenous infusion 840 mg as an optimal formulation for the treatment of PD-L1-positive inoperable or metastatic triple negative breast cancer (Chugai Press Release) - Nov 26, 2019 - "Chugai Pharmaceutical...announced that an anticancer agent/anti-PD-L1 (Programmed Death-Ligand 1) monoclonal antibody Tecentriq® Intravenous Infusion 840 mg...has been listed on the National Health Insurance (NHI) reimbursement price list and launched today. Tecentriq 840 mg is an optimal formulation to be dosed every two weeks for the treatment of PD-L1-positive hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer. This additional indication and dosage were approved on September 20, 2019."sacituzumab govitecan (IMMU-132) / ImmunomedicsIMMU-132 clinical trial estimate: Data from P3 ASCENT trial (NCT02574455) for TNBC in mid-2020 (Zacks) - Nov 25, 2019 - A subscription to Thomson ONE is required to gain full access to report 68305709; Page no: 3; REPORT TITLE: "Immunomedics, Inc.(IMMU) Zacks company report”; AUTHOR: Research Department; DATE: 11/08/2019Ibrance (palbociclib) / PfizerReal-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy (clinicaltrials.gov) - Nov 25, 2019 - P; N=1; Active, not recruiting; Sponsor: PfizerKadcyla (ado-trastuzumab emtansine) / RocheHealth Canada approves Kadcyla (trastuzumab emtansine) for the treatment of HER2-positive early breast cancer after surgery (Canada Newswire) - Nov 28, 2019 - "Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved Kadcyla® (trastuzumab emtansine) for adjuvant (after surgery) treatment of people with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) taxane and trastuzumab-based treatment...Health Canada's approval is based on results of the Phase III KATHERINE study..."National Medical Products Administration (NMPA) approves Chipscreen Bioscience’s chidamide (Epidaza) for breast cancer indication (PRNewswire) - Nov 29, 2019 - “On November 29, 2019, Shenzhen Chipscreen Biosciences Co., Ltd….announced that the company's lead innovative product Epidaza® (Chidamide), an oral subtype-selective histone deacetylase (HDAC) inhibitor…has received approval for marketing application in its second indication from NMPA. The indication includes Chidamide combined with aromatase inhibitor in postmenopausal patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer (ABC) treated with endocrine therapies for recurrence or progression.”Ogivri (trastuzumab biosimilar) / Biocon, MylanMylan and Biocon launch trastuzumab biosimilar, Ogivri (trastuzumab-dkst), in the U.S. (PRNewswire) - Dec 2, 2019 - “Mylan N.V….and Biocon Ltd….announced the U.S. launch of Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility….Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma)…. FDA approval of Ogivri was based on robust data demonstrating that Ogivri…results of the landmark HERITAGE study including overall survival data at 36 months were presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting.”Talzenna (talazoparib) / Pfizer; Keytruda (pembrolizumab) / Merck (MSD)A Study of ZN-c3 in Participants With Solid Tumors (clinicaltrials.gov) - Nov 25, 2019 - P1/2; N=360; Recruiting; Sponsor: K-Group Beta; Not yet recruiting --> Recruiting
