AstraZeneca Received FDA approval For Its Lung Cancer Drug Gefitinib

On July 13, 2015, the U. S. Food and Drug Administration approved Gefitinib (IRESSA) 250MG TABLET;ORAL for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. This approval of Gefitinib is being approved concurrently with a labeling expansion of the therascreen EGFR RGQ PCR Kit, a companion diagnostic test for patient selection.

Gefitinib is a kinase inhibitor, which first approved by FDA in May 2003 for NSCLC a type of lung cancer. In June 2005 the FDA withdrew approval for use in new patients due to lack of evidence that it extended life. However, on July 13, 2015, the FDA approved Gefitinib as a first-line treatment for NSCLC.


(According to company’s website) Oncology is a therapeutic area in which AstraZeneca has deep-rooted heritage. It will be potentially transformational for the company’s future, becoming the sixth growth platform. Our vision is to help patients by redefining the cancer treatment paradigm and one day eliminate cancer as cause of death. By 2020, we are aiming to bring six new cancer medicines to patients.

Our broad pipeline of next-generation medicines is focused on four main disease areas-lung, ovarian, breast, and haematological cancers. These are being targeted through four key platforms – immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair and antibody drug conjugates.

In lung cancer, AstraZeneca is at the forefront of development of targeted therapies, with more than 10 years’ experience in providing treatments for this challenging disease. In 2002, AstraZeneca was the first company to launch an EGFR TKI for patients with pre-treated metastatic NSCLC. We are committed to addressing the urgent unmet need for more effective treatments and are developing therapies that target all stages of the disease from primary treatment through to recurrence and re-treatment, in order to achieve sustained disease control. By making targeted, personalised treatment a reality at every stage, we hope to take important steps towards ultimately eradicating death from lung cancer.


Gefitinib is a quinazolin derivative which has the chemical name of 4-Quinazolinamine N-(3-chloro fluorophenyl)-7-methoxy-6-[3-(4-morpholinyl) propoxy] and has the following structural formula:


Gefitinib is generically claimed in US 5,457,105 and further specifically claimed in US through US 5,770,599 (Expiry: Apr 26, 2016) wherein both the patents were issued to AstraZeneca AB.


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