AstraZeneca announced that the US Food and Drug Administration (FDA) has
approved TAGRISSO™ (AZD9291) 80mg once-daily tablets for the treatment
of patients with metastatic epidermal growth factor receptor (EGFR)
T790M mutation-positive non-small cell lung cancer (NSCLC), as detected
by an FDA-approved test, who have progressed on or after EGFR tyrosine
kinase inhibitor (TKI) therapy.
AZD9291
is the only approved medicine indicated for patients with metastatic
EGFR T790M mutation-positive non-small cell lung cancer. This indication
is approved under the FDA’s accelerated approval process based on
tumour response rate and duration of response (DoR).
AZD9291
is an EGFR-TKI, a targeted cancer therapy, designed to inhibit both the
activating, sensitising mutations (EGFRm), and T790M, a genetic
mutation responsible for EGFR-TKI treatment resistance. Nearly
two-thirds of NSCLC patients who are EGFR mutation-positive and
experience disease progression after being treated with an EGFR-TKI
develop the T790M resistance mutation, for which there have been limited
treatment options.
Lung cancer is the leading cause of cancer death among both men and
women, accounting for about one-third of all cancer deaths, more than
breast, prostate and colorectal cancers combined. Lung cancer has a
five-year survival rate that is less than 20%. Approximately 85% of all
lung cancers in the US are NSCLC; 10% to 15% of these are EGFR
mutation-positive. Approximately two-thirds of patients treated with
EGFR TKI therapy will acquire resistance related to the T790M mutation
