IRESSA Receives Marketing Authorization for the Treatment of Non-Small Cell Lung Cancer in Europe
News Jul 07, 2009
AstraZeneca announced has that the European Commission has granted marketing authorization for the oral anti-cancer drug, IRESSA for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK across all lines of therapy.
The authorization is based on a submission package including two pivotal Phase III studies comparing IRESSA with chemotherapy, IPASS and INTEREST.
IRESSA acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumors. A mutation in the EGFR is a characteristic occurring in 10-15% of lung cancers in non-Asians, and studies have shown that these types of tumors are particularly sensitive to IRESSA.
Anders Ekblom, Executive Vice President for Development at AstraZeneca, said: "IRESSA is the first truly targeted treatment for lung cancer, and the EU marketing authorization represents an important step forward in the treatment of this devastating disease. For the first time, patients with EGFR mutation positive tumors will have a more effective and better tolerated alternative to chemotherapy as a first-line treatment.”
AstraZeneca will work closely with clinicians and pathology groups on a country-by-country basis to facilitate appropriate access to EGFR mutation diagnostic testing.
AstraZeneca has agreed to conduct a Follow-up Measure Study to generate further data in a Caucasian NSCLC patient population and is currently in discussion with the EMEA to finalize the study design and endpoints.
Researchers Develop New Method to Generate Human AntibodiesNews
Researchers hope their approach will help researchers rapidly generate therapeutic antibodies for the treatment of infectious diseases and other conditions such as cancer.READ MORE
Large-Scale Production of Living Brain Cells Enables Entirely New ResearchNews
After performing a biopsy on the patient, the skin cells are transformed into brain cells that effectively imitate the disease and the age of the patient.READ MORE
U.S. Study of Dapivirine Ring in Lactating Women Finds Little Drug Gets Into Breast MilkNews
The antiretroviral drug dapivirine that is released from an experimental vaginal ring to protect against HIV is absorbed in very low concentrations into breastmilk.READ MORE
Comments | 0 ADD COMMENT
EMBL Conference: European Conference of Life Science Funders and Foundations
Apr 19 - Apr 20, 2018
EMBL Course: Target Engagement in Biology and Drug Discovery
Feb 19 - Feb 23, 2018