AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing...
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
AstraZeneca’s Imfinzi (durvalumab) and Imjudo (tremelimumab) combinations have been recommended for marketing authorisation in the European Union (EU) for advanced liver and lung cancers.
The PEARL Phase III trial for AstraZeneca’s Imfinzi (durvalumab) did not achieve statistical significance for the primary endpoints of improving overall survival (OS) versus platinum-based chemotherapy as a monotherapy treatment of patients with Stage IV (metastatic) non-small cell lung cancer whose tumour cells express high levels (25% or more) of PD-L1, or in a subgroup of patients at low risk..
AstraZeneca’s Forxiga (dapagliflozin) has been recommended for approval in the European Union (EU) to extend the indication for heart failure with reduced ejection fraction (HFrEF) to cover patients across the full spectrum of left ventricular ejection fraction (LVEF) including HF with mildly reduced and preserved ejection fraction (HFmrEF, HFpEF).
AstraZeneca and MSD today announced that FDA has informed AstraZeneca that it will extend the Prescription Drug User Fee Act date by three months to provide further time for a full review of the supplementary new drug application for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of metastatic castration-resistant prostate cancer.
Updated results from the TROPION-PanTumor01 Phase I trial showed datopotamab deruxtecan (Dato-DXd) continued to demonstrate encouraging responses in patients with heavily pretreated metastatic triple-negative breast cancer (TNBC) and disease progression following standard treatment. Results were presented today at the 2022 San Antonio Breast Cancer Symposium (SABCS) (abstract #P6-10-03).
Initial results from the TROPION-PanTumor01 Phase I trial of datopotamab deruxtecan (Dato-DXd) showed encouraging and durable efficacy in patients with heavily pretreated hormone receptor (HR)-positive, HER2-low (immunohistochemistry [IHC] 1+ or IHC 2+/in-situ hybridisation [ISH] negative) or HER2-negative (IHC 0) unresectable or metastatic breast cancer.
Detailed results from the SERENA-2 Phase II trial showed AstraZeneca’s next-generation oral selective estrogen receptor degrader (ngSERD) camizestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) at both 75mg and 150mg dose levels versus Faslodex (fulvestrant) 500mg...
Detailed results from the CAPItello-291 Phase III trial showed AstraZeneca’s capivasertib in combination with Faslodex (fulvestrant) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus placebo plus Faslodex in patients with hormone receptor (HR)-positive, HER2-low or negative, locally advanced or metastatic breast cancer...
AstraZeneca and Daiichi Sankyo’s Enhertu also improved progression-free survival by 22 months vs.T-DM1 in patients previously treated with HER2-directed therapy in the DESTINY-Breast03 Phase III trial
Enhertu showed significant progression-free and overall survival improvements vs. chemotherapy in later-line HER2-positive setting in the DESTINY-Breast02 Phase III trial
Updated results fr
Calquence real-world evidence and long-term follow-up data, as well as research collaborations, will reinforce efficacy and safety across B-cell malignancies. Early clinical data will illustrate potential of multiple pipeline molecules, including TNB-486 (AZD0486), across haematologic malignancies. Research from Alexion, AstraZeneca Rare Disease, offers new insights to accelerate innovation and im
AstraZeneca (LSE/STO/Nasdaq: AZN) är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel för sjukdomar inom terapiområdena Onkologi, Sällsynta sjukdomar och Bioläkemedel, inklusive kardiovaskulära sjukdomar, njursjukdomar och metabola sjukdomar (CVRM) samt Andningsvägar och Immunologi. AstraZeneca är baserat i Cambridge i Storbritannien och bedriver verksamhet i över 100 länder. Dess innovativa läkemedel används av miljontals patienter över hela världen.
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