AstraZeneca

15 Augusti 2022 08:00

Enhertu significantly delayed disease progression in DESTINY-Breast02 Phase III trial vs. physician’s choice of treatment in patients with HER2-positive metastatic breast cancer

Positive high-level results from the DESTINY-Breast02 Phase III trial of Enhertu versus physician’s choice of treatment showed the trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.

12 Augusti 2022 08:02

Enhertu approved in the US as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a Food and Drug Administration (FDA)-approved test, and who have received a prior systemic therapy.

11 Augusti 2022 08:01

Acquisition of TeneoTwo for its clinical-stage T-cell engager completed

AstraZeneca has completed the acquisition of TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma.1 AstraZeneca will develop TNB-486 as a potential new medicine for B-cell haematologic malignancies.

9 Augusti 2022 12:02

Datopotamab deruxtecan-based combinations show promising clinical activity in patients with advanced non-small cell lung cancer

Initial results from the TROPION-Lung02 Phase Ib trial showed that datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy demonstrated promising clinical activity and a tolerable safety profile in patients with previously untreated or pretreated, advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.

8 Augusti 2022 10:31

Tagrisso plus savolitinib demonstrated 49% objective response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial

Preliminary results from the SAVANNAH Phase II trial showed that Tagrisso (osimertinib) plus savolitinib demonstrated an objective response rate of 49% in patients with epidermal growth factor receptor-mutated non-small cell lung cancer with high levels of MET overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with Tagrisso.

8 Augusti 2022 08:11

Enhertu approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

5 Augusti 2022 13:01

Calquence tablet formulation approved in the US across current indications

New formulation can be co-administered with gastric acid-reducing agents. Tablet offers equivalent efficacy, safety and consistent dosing compared to current capsule.
AstraZeneca’s new tablet formulation of Calquence (acalabrutinib) has been approved in the US for all current indications, including adult patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and for

4 Augusti 2022 08:01

Lynparza approved in EU for early breast cancer

First and only approved medicine targeting BRCA mutations in early breast cancer.
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early bre

29 Juli 2022 08:03

Michel Demaré to succeed Leif Johansson as Non-Executive Chair of the Board

AstraZeneca PLC today announced the appointment of Michel Demaré as the Chair-designate of the Board.

29 Juli 2022 08:02

AstraZeneca PLC:s resultatrapport för första halvåret 2022

Stark utveckling av intäkterna och framgång inom FoU möjliggör ytterligare investeringar i forskningsportföljen och nya lanseringar

25 Juli 2022 09:43

Enhertu granted Priority Review in the US for patients with HER2-low metastatic breast cancer

Based on DESTINY-Breast04 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2-directed therapy to demonstrate a survival benefit in this population. Application being evaluated under FDA Real-Time Oncology Review and Project Orbis.
AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enher

25 Juli 2022 08:40

Tezspire recommended for approval in the EU by CHMP for the treatment of severe asthma

First and only biologic recommended for EU approval in patients with severe asthma with no phenotype or biomarker limitations.
AstraZeneca’s Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another me

Nyhetsarkiv