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  • Freja Annamatz

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    US FDA accepts regulatory submission for Tagrisso in 1st-line EGFR-mutated non-small cell lung cancer

    Acceptance follows FDA Breakthrough Therapy Designation Tagrisso granted Priority ReviewAstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R)

    TAGRISSO (OSIMERTINIB) SHOWS CLINICAL ACTIVITY IN PATIENTS WITH LEPTOMENINGEAL DISEASE FROM LUNG CANCER

    Osimertinib data reported at ASCO 2016 demonstrated improved neurological function in patients with EGFRm NSCLC and leptomeningeal disease Latest results reinforce pre-clinical evidence that osimertinib crosses the blood-brain barrier   6 June 2016 AstraZeneca today announced clinical and safety data for Tagrisso (osimertinib) in patients with leptomeningeal (LM) disease, a complication of epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC),1 where cancer cells spread to the cerebrospinal fluid. LM is a devastating disease often

    IRESSA receives CHMP positive opinion to include blood based diagnostic testing in European label

    AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update* to the European label for IRESSA® (gefitinib). The label update will help doctors to identify lung cancer patients - based on the specific genetic drivers of their tumour - who could benefit from treatment with IRESSA but are unable to provide a suitable tumour sample. IRESSA is an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) indicated for the first line treatment of adult

    AstraZeneca and QIAGEN enter collaboration to develop diagnostic test for lung cancer patients suitable for treatment with IRESSA

    AstraZeneca today announced that it has entered into a collaboration with Netherlands-based QIAGEN to develop a non-invasive diagnostic test to identify non-small cell lung cancer (NSCLC) patients who are suitable for treatment with IRESSA®. IRESSA is an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that blocks the signals from the EGFR, which leads to tumour growth. EGFR is a protein found in abnormally high levels on the surface of many types of cancer cells, particularly non-small cell lung cancer (NSCLC) cells. Using QIAGEN’s diagnostic test, doctors will be able

    AstraZeneca and Roche announce partnership to develop companion diagnostic test for AZD9291

    AstraZeneca today announced it has entered into collaboration with Roche to develop a plasma-based companion diagnostic test to support AZD9291, AstraZeneca’s investigational compound in clinical development for non-small-cell lung cancer (NSCLC). The companion diagnostic test is designed to identify epidermal growth factor receptor (EGFR) mutations in both tumour tissue and plasma derived from patients with NSCLC, and to optimise the clinical development of AZD9291 for patients who are resistant to first-generation EGFR tyrosine kinase inhibitors (TKI). Currently, patients who have

    AstraZeneca startar kliniskt fas 3 program för selumetinib, en behandling under utveckling för patienter med icke-småcellig lungcancer

    AstraZeneca meddelar idag att den första patienten har randomiserats till det kliniska fas 3 programmet för selumetinib, en oral, potent, selektiv MEK-hämmare, vilken utvecklas som andra linjens behandling för patienter med avancerad eller metastaserad icke-småcellig lungcancer (non-small-cell lung cancer, NSCLC) med tumörer som har KRAS mutationer. Studien, SELumetinib Evaluation as Combination Therapy-1 (SELECT-1), är en randomiserad, dubbel-blind, placebo-kontrollerad studie som utvärderar säkerheten och effekten hos selumetinib i kombination med docetaxel, som andra linjens

    Skräddarsydd behandling för lungcancerpatienter

    Socialstyrelsens nya nationella riktlinjer för lungcancervård säger att personer med icke småcellig lungcancer kan erbjudas EGFR-testning – ett genombrott för personer drabbade av lungcancer. Patienter runt om i landet kan nu erbjudas individanpassad behandling, det vill säga rätt behandling till rätt patient.EGFR-testning är ett enkelt test och en banbrytande upptäckt som kan visa om tumören består av celler med en särskild sorts mutation (EGFRm+). Bär man på mutationen finns nu rekommendationer att en målstyrd behandling kan påbörjas direkt. Iressa (gefitinib) är en målstyrd behandling i

    Iressa värdefullt vid EGFR-muterad lungcancer

    Iressa (gefitinib) är värdefullt vid första linjens behandling av spridd icke-småcellig lungcancer med mutation i EGFR. Det bekräftar nya data från IPASS-studien som presenteras i dag på cancerkongressen ESMO i Milano. Inga signifikanta skillnader i total överlevnad mellan behandlingsgrupperna uppmättes. Avgörande för den totala överlevnaden var istället patientens EGFR-status. Patienter vars tumörer har en mutation i EGFR – en speciell form av lungcancer – lever längre än övriga.Överlevnadsdata från IPASS-studien bekräftar att patienter med spridd icke-småcellig lungcancer med mutation i

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