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
The European Commission (EC) has approved Merck and Pfizer’s Bavencio (avelumab), in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC). Both companies say that the approval made as a result of positive interim results from the Phase III JAVELIN Renal 101 study, which found that the combination
AbbVie has announced that the European Commission (EC) has approved its interleukin-23 (IL-23) inhibitor Risankizumab, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. The EC gave approval following results from four Phase III studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance which assessed more than 2,000 patients
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
The European Commission has approved Bristol-Myers Squibb’s Opdivo in combination with low-dose Yervoy for first-line treatment for patients with intermediate and poor risk advanced renal cell carcinoma (RCC). BMS has stated that the approval marks the first of an immuno-oncology combination therapy for patients with this type of cancer in the European Union. Clearance is
Bayer has received approval from the European Commission for its haemophilia A drug, Kovaltry (octocog alfa) in patients of all age groups. Thereby allowing it to market the product in all 28 EU member states.
Three months after US regulators gave the treatment the green light, AstraZeneca’s new lung cancer pill, Tagrisso, has won early approval for use in the EU. Tagrisso, also known by its clinical name osimertinib AZD9291, is one of six cancer medicines that AstraZeneca hopes will rebuild its sales after losing patent on older drugs.