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    http://www.astrazeneca.se
  • Kajsa Ekelund

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    Enhertu plus pertuzumab recommended for approval in the EU by CHMP as 1st-line treatment for patients with HER2-positive metastatic breast cancer

    Based on DESTINY-Breast09 Phase III trial which showed Enhertu plus pertuzumab reduced the risk of disease progression or death by 44% vs. THP with median progression-free survival exceeding three years. If approved, AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab would become first new treatment in the EU in more than a decade for 1st-line HER2-positive metastatic breast cancer.AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) in combination with pertuzumab has been recommended for approval in the European Union (EU) for the 1st-line treatment of adult patients

    Trixeo recommended for approval in the EU by CHMP for the maintenance treatment of asthma

    Recommendation based on KALOS and LOGOS Phase III trials demonstrating statistically significant and clinically meaningful benefits of AstraZeneca’s single-inhaler fixed-dose triple therapy compared with inhaled dual therapy. Approval would add second indication for Trixeo beyond COPD in Europea.AstraZeneca’s fixed-dose triple-combination Trixeo Aerosphere (budesonide/glycopyrronium/formoterol fumarate or BGF (320/28.8/9.6μg)) has been recommended for approval in the European Union (EU) for the maintenance treatment of asthma in patients 12 years of age and older who are not adequately

    Etcamah (camizestrant) in combination with a CDK4/6 inhibitor approved in the EU for 1st-line advanced ER-positive breast cancer

    Approval based on SERENA-6 Phase III trial results which showed combination reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumour mutation. First and only next-generation oral SERD and complete ER antagonist approved in 1st-line and only option in combination with all widely approved CDK4/6 inhibitors. Etcamah is 11th new AstraZeneca medicine of the 20 expected to launch by 2030.AstraZeneca’s Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been approved in the

    AstraZeneca enters exclusive global license agreement for novel oral EGFR inhibitor Zegfrovy for lung cancer with Dizal Pharmaceutical

    Complements AstraZeneca’s leading portfolio of medicines targeting EGFR mutations. Zegfrovy is approved in the US and China to treat lung cancer patients whose tumours carry exon 20 insertion mutations.   AstraZeneca has entered into an exclusive license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy.   Zegfrovy is approved in the US and China for the treatment of

    Update on CARDIO-TTRansform Phase III trial for Wainua (eplontersen) in adults with transthyretin-mediated amyloid cardiomyopathy

    The CARDIO-TTRansform Phase III trial1 for AstraZeneca and Ionis’ Wainua (eplontersen) in patients with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) did not meet the primary efficacy endpoint of the composite outcome of cardiovascular (CV) mortality and recurrent CV clinical events up to 140 weeks compared with placebo. Wainua was generally well tolerated, with a safety profile consistent with previous results.2   In this contemporary patient population treated with standard of care, including a majority on a stabiliser,3,4 adding Wainua did not provide a statistically

    Efzimfotase alfa showed bone health improvements in treatment-naïve paediatric patients with hypophosphatasia: median difference of 1.67 vs placebo in RGI-C Score at week 25 in MULBERRY Phase 3 trial

    Efzimfotase alfa demonstrated improvements in bone health in treatment-naïve paediatric patients with hypophosphatasia achieving median difference of 1.67 vs placebo in RGI-C Score at week 25 in MULBERRY Phase III trial       Efzimfotase alfa demonstrated favourable safety profile and tolerability in treatment-naïve patients and those switching from Strensiq across largest Phase III clinical programme in HPP including MULBERRY, CHESTNUT and HICKORY trials   Late-breaking results support potential of efzimfotase alfa as self-administered treatment taken every two weeks for

    Enhertu approved in the EU as first tumour agnostic HER2-directed therapy and antibody drug conjugate for patients with previously treated HER2-positive metastatic solid tumours

    Based on three Phase II trials of AstraZeneca and Daiichi Sankyo’s Enhertu which demonstrated clinically meaningful responses across a broad range of tumours.  AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment and who have no satisfactory treatment options.   The approval by the European Commission follows the positive opinion of the Committee

    Datroway[ ]recommended for approval in the EU by CHMP as 1st-line treatment for patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy

    Recommendation based on TROPION-Breast02 Phase III trial where AstraZeneca and Daiichi Sankyo’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival. If approved, Datroway has the potential to be the first TROP2-directed antibody drug conjugate for patients in the EU with a demonstrated overall survival benefit as 1st-line treatment.AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the

    Ultomiris granted Priority Review in the US as treatment for adults with immunoglobulin A nephropathy

    Based on I CAN Phase III trial results from prespecified interim analysis in which Ultomiris demonstrated 43.4% reduction in proteinuria vs placebo at 34 weeks. If approved, Ultomiris would be the first C5 complement inhibitor available for this rare kidney disease.Alexion, AstraZeneca Rare Disease’s supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab) has been accepted and granted Priority Review by the US Food and Drug Administration (FDA) for the treatment of adults with immunoglobulin A nephropathy (IgAN).     The FDA grants Priority Review to applications

    Truqap combination approved in the US as first and only targeted treatment for PTEN-deficient metastatic hormone-sensitive prostate cancer

    Based on results of CAPItello-281 which prospectively defined PTEN-deficient disease and showed Truqap combination reduced risk of radiographic disease progression or death by 19%. First-in-class AKT inhibitor moves into second tumour type to address an aggressive form of prostate cancer associated with poor prognosis.AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and prednisone has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer,

    Elecoglipron, an oral small molecule GLP-1 RA, moves to Phase III programme and unlocks next chapter in AstraZeneca’s cardiometabolic and kidney portfolio

    11.8% weight loss achieved at 36 weeks in adults with obesity or overweight in VISTA Phase IIb trial. HbA1c lowered by 1.9% at 26 weeks in adults with type 2 diabetes in SOLSTICE Phase IIb trial. Extensive Phase III programme for elecoglipron planned including outcome trials.Positive results from the VISTA and SOLSTICE Phase IIb trials of elecoglipron, an oral small molecule GLP-1 receptor agonist (GLP-1 RA), unlock the next chapter in AstraZeneca's ambition to develop therapies that improve cardiometabolic and kidney health and reduce weight-related complications. These results, presented

    Ultomiris demonstrated 43.4% reduction in proteinuria vs placebo in adults with immunoglobulin A nephropathy at 34 weeks in I CAN Phase III trial

    Rapid reduction in proteinuria observed as early as week 10 and sustained through week 34, supporting potential of Ultomiris as a disease-modifying treatment. Results showed treatment effect consistent across subgroups.Positive results from a prespecified interim analysis of the I CAN Phase III trial evaluating Ultomiris (ravulizumab) demonstrated a statistically significant and clinically meaningful reduction in proteinuria from baseline, based on 24-hour urine protein creatinine ratio (UPCR), compared to placebo at week 34 in adults with immunoglobulin A nephropathy (IgAN) who are at risk

    Camizestrant combination delayed time to first progression by 55% and to second progression by 37% in patients with advanced HR-positive breast cancer with an emergent ESR1 mutation in SERENA-6 trial

    Switching to camizestrant led to a 99% median reduction in total ctDNA vs. a 64% increase for patients who remained on standard of care. 51% of patients receiving the camizestrant combination achieved total ctDNA clearance vs. 1.9% with standard of care – early total ctDNA clearance was associated with an improvement in long-term outcome.Further positive results from the Phase III SERENA-6 trial showed AstraZeneca's camizestrant plus a cyclin-dependent kinase (CDK) 4/6 inhibitor – palbociclib, ribociclib or abemaciclib – maintained its progression-free survival (PFS) benefit with longer

    Imfinzi plus Imjudo combined with lenvatinib and TACE reduced the risk of disease progression or death by 30% in embolisation-eligible unresectable liver cancer in EMERALD-3 Phase III trial

    Positive overall survival trend in favour of STRIDE regimen with lenvatinib and TACE.Positive results from the EMERALD-3 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab) in combination with Imjudo (tremelimumab), lenvatinib and transarterial chemoembolisation (TACE), demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolisation. Patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab

    CARES Phase III clinical programme did not meet primary endpoint in overall AL amyloidosis population, however, demonstrated anselamimab as potential first anti-fibril therapy in kappa AL amyloidosis

    Anselamimab demonstrated 62% improvement in survival and 71% reduction in cardiovascular hospitalisations in prespecified kappa light-chain amyloidosis subgroup. Results published in the Journal of Clinical Oncology and will be presented at 2026 American Society of Clinical Oncology Annual Meeting.The global CARES Phase III clinical programme showed that treatment with anselamimab, a potential first-in-class anti-fibril therapy, resulted in nominally statistically significant and highly clinically meaningful benefit in adults with advanced kappa light chain (AL) amyloidosis as first-line

    Imfinzi approved in the US in first and only immunotherapy combination for patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer

    Based on POTOMAC Phase III trial results which showed a 32% reduction in the risk of high-risk disease recurrence, progression or death after one year of Imfinzi added to BCG vs. BCG alone.AstraZeneca’s Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy has been approved in the US for the treatment of adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). The approval by the Food and Drug Administration (FDA) is based on positive results 

    US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data

    The US Food and Drug Administration (FDA) has informed AstraZeneca that it will extend the Prescription Drug User Fee Act (PDUFA) date to review additional data requested to support the New Drug Application (NDA) for camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) for the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation.   The NDA is based on positive results from the pivotal SERENA-6 Phase III trial presented at

    Datroway approved in the US as first TROP2-directed antibody drug conjugate for 1st-line treatment of patients with metastatic triple-negative breast cancer who are not PD-1/PD-L1 inhibitor candidates

    AstraZeneca and Daiichi Sankyo’s Datroway is the only TROP2-directed antibody drug conjugate to prolong overall survival in this setting vs. chemotherapy, with an unprecedented median overall survival of approximately two years based on the TROPION-Breast02 Phase III trial. Datroway has the potential to become the new standard of care in this setting.AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1

    Enhertu recommended for approval in the EU by CHMP for patients with previously treated HER2-positive metastatic solid tumours

    Based on three Phase II trials of AstraZeneca and Daiichi Sankyo’s Enhertu which showed clinically meaningful responses across a broad range of tumours. If approved, Enhertu would become the first HER2-directed therapy and antibody drug conjugate to receive a tumour agnostic indication in the EU.AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior

    Camizestrant in combination with a CDK4/6 inhibitor recommended for approval in the EU by CHMP for 1st-line advanced ER-positive breast cancer

    Recommendation based on SERENA-6 Phase III trial results which showed combination reduced the risk of disease progression or death by 56% in patients with an emergent ESR1 tumour mutation. If approved, camizestrant has the potential to reshape 1st-line treatment for patients in Europe with this type of advanced breast cancer.AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) has been recommended for approval in the European Union (EU) for the treatment of adult patients with estrogen receptor (ER)-positive,

    AstraZeneca to showcase Phase III data in liver, breast and bladder cancers and potential first-in-class rare disease therapy at ASCO 2026

    EMERALD-3 late-breaking presentation will showcase benefit of Imfinzi and Imjudo in early liver cancer. Phase III data from SERENA-6, DESTINY-Breast09 and TROPION-Breast02 span all three major subtypes of metastatic breast cancer.CARES Phase III results will demonstrate highly clinically meaningful benefit  of anti-fibril therapy, anselamimab, for kappa light chain amyloidosis.AstraZeneca advances its ambition to eliminate cancer as a cause of death and transform outcomes for people living with rare diseases with new data across its diverse, industry-leading portfolio and pipeline at

    Enhertu approved in the US for two new indications for patients with HER2-positive early breast cancer

    Approved for use before surgery based on DESTINY-Breast11 Phase III trial. Approved for use following surgery based on DESTINY-Breast05 Phase III trial. Two new indications bring AstraZeneca and Daiichi Sankyo’s Enhertu into curative-intent setting, reinforcing its role across stages of HER2-positive breast cancer.AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved by the US Food and Drug Administration (FDA) for both the neoadjuvant and adjuvant treatment of patients with HER2-positive early breast cancer based on results from the DESTINY-Breast11 and

    Baxfendy approved in the US as the first and only aldosterone synthase inhibitor treatment for adults with hypertension

    Approval based on BaxHTN Phase III results showing statistically significant and clinically meaningful reduction in systolic blood pressure in patients with uncontrolled or resistant hypertension. Baxfendy 2mg lowered systolic blood pressure by 15.7 mmHg (9.8 mmHg placebo-adjusted) from baseline in BaxHTN trial.AstraZeneca’s Baxfendy (baxdrostat) has been approved in the US as a first-in-class aldosterone synthase inhibitor (ASI) for the treatment of hypertension in combination with other antihypertensive medications, to lower blood pressure in adults who are not adequately controlled.

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