AZ's Tagrisso approved for untreated lung cancer in US

AstraZeneca Amenities Building - Mississauga - Sept 2005
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AstraZeneca’s Tagrisso looks set to gain further traction after the FDA approved it in first-line treatment for lung cancer patients with a certain mutation.

The approval, for untreated patients with metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations, is likely to drive Tagrisso (osimertinib) to new heights after first approval in late 2015.

Already on the cusp of becoming a blockbuster in its already-approved use in second line NSCLC EGFR mutated lung cancer with a T790M mutation, trial evidence showed it could stay the growth of cancer for an “unprecedented” period compared with standard care in first line use.

Tagrisso was originally developed to overcome a problem that emerges in around half of patients treated with AZ’s older drug Iressa (gefitinib), and other tyrosine kinase inhibitors -  a single amino acid mutation in cancer cells that blocks the drug’s action.

But results of the phase 3 FLAURA trial unveiled earlier this week have shown Tagrisso is also more effective than Iressa or Roche’s Tarceva (erlotinib) in previously untreated patients too.

Median progress-free survival in FLAURA was 18.9 months in patients treated with Tagrisso, compared with 10.2 months in those treated with standard therapy of either Iressa or Tarceva.

There was also an improvement in the proportion of patients responding to Tagrisso compared with standard therapy (77% versus 69%), and duration of response (17.6 months compared with 9.6 months).

Suresh Ramalingam

Dr Suresh Ramalingam, principal investigator of the FLAURA trial, from Winship Cancer Institute of Emory University, Atlanta, said: “The approval of osimertinib in the first-line setting represents a major advance in the treatment of patients with EGFR mutations and a significant change in the treatment paradigm. Osimertinib provides robust improvements in progression-free survival with no unexpected safety signals compared to the previous generation of EGFR inhibitors.”

Regulators in the EU and Japan are reviewing Tagrisso in the 1st-line treatment indication with regulatory decisions anticipated in the second half of this year.