Tags : EU

Regulatory

Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) Receives EU’s Approval

Shots: The approval is based on pivotal P-II DESTINY-Breast01 study involves assessing of Enhertu (5.4 mg/kg) in 184 patients as a monothx. for patients with unresectable/m-HER2+ BC prior treated with trastuzumab emtansine Results: @median follow up of 20.5mos., ORR (61.4%); CRR (54.9%); mDoR (20.8mos.). The safety of therapy has been evaluated in a pooled analysis […]Read More

Regulatory

Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for

Shots: The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine The trial demonstrated a meaningful & durable activity in patients who had received two or more prior anti-HER2 therapies. The safety & tolerability profile of the therapy was consistent with […]Read More

Clinical Trials

Pfizer and BioNTech to Supply EU with up to 200M

Shots: The companies sign an agreement with the EC to supply 200M doses of BNT162b2 mRNA-based vaccine candidate against SARS-CoV-2 to EU member states, with an option to request an additional 100M doses Deliveries are anticipated to start by the end of 2020, following clinical success and regulatory authorization. The companies expect to produce ~1.3B […]Read More

Regulatory

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L

Shots: The approval is based on a biomarker subgroup analysis of P-III PAOLA-1 study assessing Lynparza + bevacizumab vs bevacizumab alone as 1L maintenance treatment in patients with newly diagnosed advanced FIGO Stage III-IV high-grade serous/ endometrioid ovarian, fallopian tube, peritoneal cancer who had CR/PR to 1L treatment with Pt. based CT and bevacizumab Results: reduction […]Read More

Regulatory

AstraZeneca’s Trixeo Aerosphere Receives CHMP’s Recommendation for Approval to Treat

Shots: The CHMP’s positive opinion is based on P-III ETHOS & KRONOS studies, which are a part of AstraZeneca’s P-III ATHENA program assessing Trixeo Aerosphere in 15500+ patients globally across 11 trials P-III ETHOS study results reported that triple-combination therapy showed a reduction in the rate of moderate or severe exacerbations compared with the Bevespi […]Read More