• Center on Health Equity and Access
  • Clinical
  • Health Care Cost
  • Health Care Delivery
  • Insurance
  • Policy
  • Technology
  • Value-Based Care

Astra Files NDA for Iressa as First-Line in NSCLC

Article

Iressa, an EGFR inhibitor, is widely used in the treatment of advanced, metastatic NSCLC.

US regulators have accepted AstraZeneca’s New Drug Application for Iressa (gefitinib) as a targeted monotherapy for the first-line treatment of certain lung cancer patients.

The drug giant is seeking approval to market Iressa for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who test positive for an epidermal growth factor receptor mutation (EGFRm).

AZ is working with Qiagen in the US to develop a companion diagnostic test to guide the use of Iressa in this setting; In Europe, their collaboration resulted in the drug becoming the first EGFR tyrosine kinase inhibitor to have a European label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option.

Link to the complete news on Pharma Times: http://bit.ly/1tzkhJ8

Related Videos
Judith Alberto, MHA, RPh, BCOP, director of clinical initiatives, Community Oncology Alliance
Mila Felder, MD, FACEP, emergency physician and vice president for Well-Being for All Teammates, Advocate Health
Will Shapiro, vice president of data science, Flatiron Health
Mila Felder, MD, FACEP, emergency physician and vice president for Well-Being for All Teammates, Advocate Health
Mila Felder, MD, FACEP, emergency physician and vice president for Well-Being for All Teammates, Advocate Health
Will Shapiro, vice president of data science, Flatiron Health
Jonathan E. Levitt, Esq, Frier Levitt, LLC
Judy Alberto, MHA, RPh, BCOP, Community Oncology Alliance
Mila Felder, MD, FACEP, emergency physician and vice president for Well-Being for All Teammates, Advocate Health
Emily Touloukian, DO, Coastal Cancer Center
Related Content
© 2024 MJH Life Sciences
AJMC®
All rights reserved.