Noticias y eventos de AstraZeneca PLC (AZN)AZNAstraZeneca PLC

AstraZeneca's Zegfrovy Receives FDA Accelerated Approval for NSCLC Treatment

AstraZeneca announced the US availability of Zegfrovy for the treatment of adults with locally advanced or metastatic non-small cell lung cancer, NSCLC, whose tumors have epidermal growth factor receptor, EGFR, exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy. The US Food and Drug Administration granted accelerated approval to Zegfrovy based on results from the WU-KONG1B trial. In the open-label, dose randomization clinical trial, Zegfrovy demonstrated a confirmed overall response rate of 46% and a median duration of response of 11.1 months in those responders. Seventy-two percent of responding patients observed duration of response for at least six months. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

AstraZeneca's Ultomiris Approved for IgAN Patients

The company states: "Alexion, AstraZeneca Rare Disease's Ultomiris - ravulizumab - has been approved in the US to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression. This indication is approved under accelerated approval based on reduction of proteinuria. It has not been established whether Ultomiris slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the ongoing I CAN Phase III trial evaluating Ultomiris in adults with IgAN who are at risk of disease progression. The trial is ongoing and will assess the primary endpoint of change from baseline in estimated glomerular filtration rate (eGFR) at week 106, with data intended to support traditional FDA approval. The approval follows Priority Review by the US Food and Drug Administration (FDA) based on positive results from a prespecified interim analysis of the I CAN trial. Results showed Ultomiris demonstrated a 43.4% reduction in proteinuria vs placebo at 34 weeks. Ultomiris is administered intravenously every eight weeks in adults (based on body weight), following a loading dose."

AstraZeneca and Amgen's Tezspire Trial Results Show Significant Improvements

Full results from the "positive" Phase 3 CROSSING trial showed that AstraZeneca (AZN) and Amgen's (AMGN) Tezspire demonstrated statistically significant and clinically meaningful improvements in the co-primary endpoints of histologic remission and the frequency and severity of dysphagia in adolescent and adult patients with symptomatic and uncontrolled eosinophilic esophagitis, despite continued treatment with background medications. These improvements were observed at week 24 in both doses tested compared to placebo. Efficacy was sustained in both doses through week 52, as measured in key secondary endpoints. Results from the CROSSING trial were presented in a late-breaking oral presentation at United European Gastroenterology Week 2026 in Barcelona, Spain. Treatment with Tezspire, administered subcutaneously every four weeks, achieved histologic remission for 64.8% for the 210mg dose and 68.9% for the 420mg dose of patients at week 24, compared to 3.5% of patients on placebo. Tezspire also reduced the frequency and severity of dysphagia symptoms by 18.8 points for the 210mg dose and 22.0 points for the 420mg dose from baseline vs. 14.7 points on placebo, as measured by the Dysphagia Symptom Questionnaire score, a patient-reported outcome measure. These results were sustained through week 52, assessed in key secondary endpoints: 67.8% (210mg dose) and 63.3% (420mg dose) of patients taking Tezspire achieved histologic remission vs. 5.4% on placebo and there was continued symptom improvement through week 52, with patients taking Tezspire achieving an average reduction from baseline of 22.1 points (210mg dose) and 24.0 points (420mg dose) in the DSQ score vs. 13.2 points on placebo.