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  • AstraZeneca
    Karlebyhus, Astraallén 151 85 SÖDERTÄLJE
    08-553 260 00
    08-553 290 00
    http://www.astrazeneca.se
  • Kajsa Ekelund

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    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.

    Imfinzi + EV improves EFS & OS in bladder cancer

    Perioperative Imfinzi plus neoadjuvant EV showed statistically significant and clinically meaningful improvements in event-free survival and overall survival in muscle-invasive bladder cancer in the Phase III VOLGA trial   Perioperative Imfinzi plus Imjudo and neoadjuvant EV showed a statistically significant and clinically meaningful improvement in event-free survival and a favourable trend for overall survival.   High-level results from a planned interim analysis of the VOLGA Phase III trial showed perioperative treatment with Imfinzi (durvalumab) in combination with

    Eneboparatide normalised serum calcium and achieved independence from active vitamin D and oral calcium supplements in 31.1% of adults with hypoparathyroidism at week 24 in CALYPSO Phase III trial

    Urinary calcium excretion was normalised in 56.6% of patients who were hypercalciuric at baseline. Additional results through week 52 further support potential of eneboparatide to enable functional restoration of parathyroid hormone activity, including symptom and quality of life improvements, benefit to kidney function and preservation of bone health.Positive results from the CALYPSO Phase III trial showed that eneboparatide (AZP-3601), an investigational parathyroid hormone (PTH) 1 receptor agonist, met its composite primary endpoint, demonstrating a statistically significant and

    Truqap recommended by FDA Advisory Committee for PTEN-deficient metastatic hormone-sensitive prostate cancer

    ODAC overwhelming majority voted that Truqap plus abiraterone and ADT demonstrated a favourable benefit risk profile for patients based on the CAPItello-281 Phase III trial results. First and only targeted treatment combination to demonstrate benefit in this subtype of prostate cancer addresses significant unmet patient need.The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognised a favourable benefit risk profile for AstraZeneca’s Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) for the treatment of

    Update on FDA Advisory Committee vote on camizestrant in combination with a CDK4/6 inhibitor for advanced HR-positive breast cancer

    The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) did not reach a majority vote on the benefit risk profile of AstraZeneca’s 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, based on the SERENA-6 Phase III trial. The Committee voted 3 to 6. In July 2025, the FDA accepted the New Drug Application (NDA) for camizestrant in

    Breztri approved in the US for asthma as first and only triple therapy for patients 12 years of age and older

    Approval 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 is second indication for Breztri beyond COPD.AstraZeneca’s fixed-dose triple-combination therapy Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate or BGF 320/36/9.6μg) has been approved in the US for the maintenance treatment of asthma in adult and paediatric patients 12 years of age and older. Breztri is a single-inhaler that combines the efficacy

    Saphnelo approved in the US for subcutaneous self-administration as a new autoinjector for the treatment of systemic lupus erythematosus

    First-in-class Saphnelo Pen now offers greater flexibility and convenience, reaching a wider group of patients.AstraZeneca’s Saphnelo (anifrolumab) has been approved in the US for self-administration as a once-weekly autoinjector, the Saphnelo Pen, for the treatment of adult patients with systemic lupus erythematosus (SLE) on top of standard therapy. The approval by the US Food and Drug Administration (FDA) was based on results from the Phase III TULIP-SC trial, which showed that subcutaneous (SC) administration of Saphnelo led to a statistically significant and clinically meaningful

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