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Karl-Johan Karlsson

Karl-Johan Karlsson

Presskontakt Tf presschef, AstraZeneca AB +46735801268
Mathias Holm Pedersen

Mathias Holm Pedersen

Presskontakt Kommunikationschef, AstraZeneca Nordic +45 22937730

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Lynparza plus abiraterone reduced risk of disease progression by 34% vs. standard-of-care in 1st-line metastatic castration-resistant prostate cancer

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Imfinzi plus tremelimumab demonstrated unprecedented survival in 1st-line unresectable liver cancer with 31% of patients alive at three years

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Imfinzi plus chemotherapy reduced risk of death by 20% in 1st-line advanced biliary tract cancer

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Forxiga approved in China for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes

Forxiga approved in China for the treatment of chronic kidney disease in patients at risk of progression with and without type-2 diabetes

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Enhertu granted Priority Review in the US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer

Enhertu granted Priority Review in the US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer

AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enhertu for the treatment of adult patients in the US with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have a HER2 (ERBB2) mutation and who have received a prior systemic therapy. The application has also been granted Priority Review.

Evusheld significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations

Evusheld significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations

Detailed results from the PROVENT Phase III pre-exposure prophylaxis trial showed that AstraZeneca’s Evusheld, formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six month follow-up analysis, compared to placebo. There were no cases of severe disease or COVID-19 related deaths in the Evusheld group through the six-month follow-up.

AstraZeneca enters license agreement with KYM Biosciences for CMG901, a Claudin-18.2 antibody drug conjugate

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AstraZeneca and KYM Biosciences Inc.i have entered into a global exclusive licence agreement for CMG901, a potential first-in-class antibody drug conjugate (ADC) targeting Claudin 18.2, a promising therapeutic target in gastric cancer. Under the licence agreement, AstraZeneca will be responsible for the research, development, manufacture and commercialisation of CMG901 globally.

Imfinzi and tremelimumab with chemotherapy demonstrated sustained survival benefit in metastatic non-small cell lung cancer, nearly doubling the number of patients alive after three years vs. chemotherapy

Imfinzi and tremelimumab with chemotherapy demonstrated sustained survival benefit in metastatic non-small cell lung cancer, nearly doubling the number of patients alive after three years vs. chemotherapy

Updated results after approximately four years of follow-up of the POSEIDON Phase III trial showed a limited course of tremelimumab when added to AstraZeneca’s Imfinzi (durvalumab) plus four cycles of chemotherapy demonstrated a sustained improvement in overall survival (OS) compared to chemotherapy alone in the 1st-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer.

Imfinzi plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer in the TOPAZ-1 Phase III trial, reducing the risk of death by 24% in additional follow-up

Imfinzi plus chemotherapy further improved overall survival benefit in advanced biliary tract cancer in the TOPAZ-1 Phase III trial, reducing the risk of death by 24% in additional follow-up

Updated results from the TOPAZ-1 Phase III trial showed AstraZeneca’s Imfinzi (durvalumab), in combination with standard-of-care chemotherapy demonstrated a clinically meaningful and durable overall survival (OS) benefit as a treatment for patients with advanced biliary tract cancer (BTC).

Tagrisso demonstrated 5.5-year median disease-free survival in the adjuvant treatment of patients with EGFR-mutated lung cancer

Tagrisso demonstrated 5.5-year median disease-free survival in the adjuvant treatment of patients with EGFR-mutated lung cancer

Updated results from the pivotal ADAURA Phase III trial showed that AstraZeneca’s Tagrisso demonstrated a sustained, clinically meaningful improvement in disease-free survival compared to placebo in the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumour esection with curative intent.

Enhertu continues to demonstrate clinically meaningful tumour response in patients with HER2-mutant metastatic non-small cell lung cancer

Enhertu continues to demonstrate clinically meaningful tumour response in patients with HER2-mutant metastatic non-small cell lung cancer

Detailed positive results from an interim analysis of the DESTINY-Lung02 Phase II trial showed Enhertu demonstrated clinically meaningful tumour responses in previously-treated patients with HER2-mutant unresectable and/or metastatic non-squamous non-small cell lung cancer. Results will be presented today as a late-breaking presentation at the European Society for Medical Oncology Congress 2022.

Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of COVID-19

Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of COVID-19

AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID 19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID 19.

Danicopan (ALXN2040) add-on to Ultomiris or Soliris met primary endpoint in ALPHA Phase III trial for patients with paroxysmal nocturnal haemoglobinuria who experience clinically significant extravascular haemolysis

Danicopan (ALXN2040) add-on to Ultomiris or Soliris met primary endpoint in ALPHA Phase III trial for patients with paroxysmal nocturnal haemoglobinuria who experience clinically significant extravascular haemolysis

A prespecified interim analysis of the ALPHA Phase III trial evaluating danicopan (ALXN2040), an investigational, oral factor D inhibitor, as an add-on to C5 inhibitor therapy Ultomiris (ravulizumab) or Soliris (eculizumab) showed positive high-level results in patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience clinically significant extravascular haemolysis (EVH).

Ultomiris met primary endpoint in CHAMPION-NMOSD Phase III trial in adults with neuromyelitis optica spectrum disorder

Ultomiris met primary endpoint in CHAMPION-NMOSD Phase III trial in adults with neuromyelitis optica spectrum disorder

Positive high-level results from the open-label Phase III CHAMPION-NMOSD trial showed that Ultomiris achieved a statistically significant and clinically meaningful reduction in the risk of relapse in adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD) compared to the external placebo arm from the pivotal Soliris PREVENT clinical trial.

Enhertu approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen

Enhertu approved in the US for patients with HER2-positive metastatic breast cancer treated with a prior anti-HER2-based regimen

AstraZeneca and Daiichi Sankyo’s Enhertu has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

Lynparza approved in China as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer

Lynparza approved in China as 1st-line maintenance treatment with bevacizumab for HRD-positive advanced ovarian cancer

AstraZeneca and MSD’s Lynparza (olaparib) has been approved in China for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status

Enhertu reduced the risk of disease progression or death by 50% vs. chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive and HR-negative disease

Enhertu reduced the risk of disease progression or death by 50% vs. chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive and HR-negative disease

Enhertu reduced the risk of disease progression or death by 50% vs. chemotherapy in patients with HER2-low metastatic breast cancer with HR-positive and HR-negative disease. AstraZeneca and Daiichi Sankyo’s Enhertu also improved median overall survival by more than 6 months vs. chemotherapy in all patients evaluated in DESTINY-Breast04.

Evusheld significantly prevented COVID-19 disease progression or death in TACKLE Phase III treatment trial

Evusheld significantly prevented COVID-19 disease progression or death in TACKLE Phase III treatment trial

Detailed results from the TACKLE Phase III outpatient treatment trial showed AstraZeneca’s Evusheld (tixagevimab and cilgavimab, formerly AZD7442) provided clinically and statistically significant protection against progression to severe COVID-19 or death from any cause compared to placebo, with treatment with Evusheld earlier in the disease course leading to more favourable outcomes.

Update on US regulatory review of Lynparza in combination with abiraterone for metastatic castration-resistant prostate cancer

Update on US regulatory review of Lynparza in combination with abiraterone for metastatic castration-resistant prostate cancer

AstraZeneca and MSD today announced that the US Food and Drug Administration (FDA) will convene a meeting of the Oncologic Drugs Advisory Committee (ODAC) to discuss the supplemental new drug application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).

Lynparza recommended for approval in the EU by CHMP as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer

Lynparza recommended for approval in the EU by CHMP as adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer

AstraZeneca and MSD’s Lynparza (olaparib) has been recommended for marketing authorisation 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 HER2-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

Imfinzi plus chemotherapy significantly improved pathologic complete response in AEGEAN Phase III trial in resectable non-small cell lung cancer

Imfinzi plus chemotherapy significantly improved pathologic complete response in AEGEAN Phase III trial in resectable non-small cell lung cancer

Positive high-level results from a planned interim analysis of the AEGEAN Phase III trial showed treatment with AstraZeneca’s Imfinzi in combination with neoadjuvant chemotherapy before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete response compared to neoadjuvant chemotherapy alone for patients with resectable non-small cell lung cancer.

AstraZeneca and MSD present final results of key secondary overall survival endpoint from Phase III PROpel trial at ASCO GU Cancers Symposium

AstraZeneca and MSD present final results of key secondary overall survival endpoint from Phase III PROpel trial at ASCO GU Cancers Symposium

Results from the final prespecified overall survival (OS) analysis of the PROpel Phase III trial in metastatic castration-resistant prostate cancer (mCRPC) showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone demonstrated median overall survival (OS) of 42.1 months versus 34.7 months for abiraterone plus placebo.

Enhertu approved in the EU for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens

Enhertu approved in the EU for patients with HER2-positive metastatic breast cancer treated with one or more prior anti-HER2-based regimens

Approval broadens indication for AstraZeneca and Daiichi Sankyo’s Enhertu across Europe to earlier use in HER2-positive metastatic breast cancer. Based on ground-breaking DESTINY-Breast03 results in which Enhertu demonstrated a 72% reduction in the risk of disease progression or death vs. trastuzumab emtansine (T-DM1).
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been a

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

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

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

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

Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with generalised myasthenia gravis

Ultomiris recommended for approval in the EU by CHMP for the treatment of adults with generalised myasthenia gravis

First and only long-acting C5 complement inhibitor showed early effect and demonstrated clinical improvement in activities of daily living.
Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) anti

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

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.

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

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.

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

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.

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

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.

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

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.

New data show Farxiga significantly lowers the risk of cardiovascular death in patients with heart failure

New data show Farxiga significantly lowers the risk of cardiovascular death in patients with heart failure

Today, new results from a pre-specified, patient level, pooled analysis from the Phase III DAPA-HF and DELIVER trials demonstrated mortality benefit of Farxiga (dapagliflozin), compared to placebo, in patients with heart failure (HF). These results were presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain and simultaneously published in Nature Medicine.

Enhertu showed clinically meaningful and durable responses across multiple HER2-expressing tumour types in DESTINY-PanTumor02 Phase II trial

Enhertu showed clinically meaningful and durable responses across multiple HER2-expressing tumour types in DESTINY-PanTumor02 Phase II trial

Positive high-level results from an analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pretreated patients.

Update to contractual arrangements between AstraZeneca, Swedish Orphan Biovitrum AB and Sanofi

Update to contractual arrangements between AstraZeneca, Swedish Orphan Biovitrum AB and Sanofi

AstraZeneca, Swedish Orphan Biovitrum AB (publ) (Sobi) and Sanofi have updated and simplified their contractual arrangements relating to the development and commercialisation of nirsevimab in the US. Given the upcoming launch of nirsevimab in the US and other markets, simplification of the prior arrangements clarifies the roles and responsibilities of relevant parties.
Under the updated arra

ECCMID data reinforces AstraZeneca’s commitment to transform protection for the most vulnerable by advancing science in vaccines and immune therapies

ECCMID data reinforces AstraZeneca’s commitment to transform protection for the most vulnerable by advancing science in vaccines and immune therapies

AstraZeneca will highlight new data across its Vaccines and Immune Therapies portfolio at the 33rd European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), 15 – 18 April 2023, reinforcing its ambition to provide long-lasting immunity for millions of people globally. The company will present 15 abstracts, including four oral presentations, at the event.

Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer

Update on FDA Advisory Committee vote on Lynparza plus abiraterone for metastatic castration-resistant prostate cancer

The Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) has recognised a favourable benefit risk profile for AstraZeneca and MSD’s Lynparza (olaparib) plus abiraterone and prednisone or prednisolone for the treatment of adult patients with BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) based on the PROpel Phase III trial.

Tagrisso plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial

Tagrisso plus chemotherapy demonstrated strong improvement in progression-free survival for patients with EGFR-mutated advanced lung cancer in FLAURA2 Phase III trial

Positive high-level results from the FLAURA2 Phase III trial showed Tagrisso in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to Tagrisso alone for patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated non-small cell lung cancer.

Imfinzi plus Lynparza and Imfinzi alone both significantly improved progression-free survival in advanced endometrial cancer when added to chemotherapy

Imfinzi plus Lynparza and Imfinzi alone both significantly improved progression-free survival in advanced endometrial cancer when added to chemotherapy

Positive high-level results from the DUO-E Phase III trial showed Imfinzi (durvalumab) in combination with platinum-based chemotherapy followed by either Imfinzi plus Lynparza (olaparib) or Imfinzi alone as maintenance therapy both demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy alone in...

Om AstraZeneca

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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