AstraZeneca (AZ) has been granted a priority review by the US Food and Drug Administration (FDA) for a new four-week, fixed-dose regimen of its PD-1 inhibitor Imfinzi. AZ have stated that if the new regimen is approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500mg in approved indications. This includes unresectable,
The European Commission has approved AstraZeneca (AZ) and Merck/MSD’s PARP-inhibitor Lynparza for the treatment of patients with BRCA-mutated metastatic pancreatic cancer. The approval was based on results from the phase 3 POLO trial of Lynparza in advanced pancreatic cancer patients whose tumours carry BRCA mutations. About 5-7% of metastatic pancreatic cancers are caused by mutations in one
AstraZeneca’s Brilinta has been cleared by US regulators to cut the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD). The decision was based on data from the Phase III THEMIS trial, which showed a significant 10% reduction in the primary composite endpoint of major adverse cardiovascular (CV)
FDA has issued a complete response letter for the New Drug Application (NDA) for PT010 (budesonide/glycopyrronium/formoterol fumarate); Paul Jeng, Senior Pharma Analyst at GlobalData, a leading data and analytics company, offers his perspective: “In an attempt to close the gap with chief chronic obstructive pulmonary disease (COPD) rival GlaxoSmithKline (GSK), AstraZeneca pushed to file an
AstraZeneca and MSD‘s Olaparib has been approved by the European Commission for the treatment of germline BRCA-mutated HER2-negative metastatic breast cancer. The approval allows for the first PARP inhibitor approved in Europe for patients with this difficult-to-treat disease, and the third EU approval for Olaparib. The European commission made the approval based on data from
AstraZeneca has received approval from the European Commission for the use of Dapagliflozin as an adjunct to insulin to treat type-1 diabetes. The indication covers adult patients with a BMI of 27 or more who often cannot achieve adequate glycaemic control with insulin alone, despite optimal therapy. Dapagliflozin is said to be the first AstraZeneca drug
AstraZeneca’s durvalumab has been approved in Europe for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC). The decision enables doctors to prescribe the drug for adults with stage III NSCLC whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The
AZ’s Tagrisso has been given a go-ahead in Europe for first-line use to treat EGFR-mutated non-small cell lung cancer (NSCLC), offering a new line of attack at this stage of the disease. The decision was based on clinical data from the Phase III FLAURA trial, showing that progression free survival in patients taking Tagrisso (osimertinib)
In final guidance, NICE backs usage of AstraZeneca’s drug as long-term treatment for patients who have suffered a heart attack and are at high risk of a further cardiovascular event. The UK agency’s final guidance recommends the anti-clotting therapy for NHS use at a lower dosage than was previously available, backing AZ’s treatment as a
The European Commission has approved AstraZeneca’s Qtern, a two-drug therapy for type 2 diabetes that was turned down in the US last year. The diabetes therapy combines active ingredients in AZ’s DPP-4 inhibitor Onglyza (saxagliptin) with SGLT2 inhibitor Farxiga/Forixiga (saxagliptin), making it the second drug of its type on the market after Eli Lilly and
