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
Shots: Imfinzi has been approved in the EU and the UK for an additional dosing option (1500mg, fd, q4w) in LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT New option extends dosing from 2 to 4wks. thus, reducing […]Read More
Shots: AstraZeneca’s Imfinzi durvalumab (1500mg, fd, q4w) is recommended for approval in the EU for an additional dosing option in the approved indication of LA, unresectable NSCLC in adults whose tumors express PD-L1 on at least 1% of tumor cells and whose disease has not progressed following platinum-based CRT The CHMP opinion is based on […]Read More
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
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
Shots: J&J has resumed recruitment, enrolment, and vaccination in all studies of its COVID-19 vaccine across the EU, after a temporary pause. Trials in the US, South Africa, and some Latin American countries are already ongoing Clinical trials to be resumed are the P-IIa studies in Germany, the Netherlands, and Spain and P-I/IIa study in […]Read More
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
Shots: The approval is based on P-III DAPA-HF study involves assessing of Forxiga (10mg) + SOC vs PBO +SOC in 4744 patients with heart failure and reduced ejection fraction (LVEF ≤ 40%) with/out T2D Results: reduction in risk of the composite outcome by 26%, with both components of the 1EPs (first occurrence of a worsening […]Read More
Shots: The approval is based on PRIMA study assessing Zejula (300mg qd), later amended to incorporate an individualised starting dose of Zejula (200 mg or 300 mg, qd) based on the patient’s baseline weight and/or platelet count Results: The PRIMA study improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd […]Read More
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
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