EU issues full approval for AZ’ Tagrisso

European regulators have now issued a full approval for AstraZeneca’s lung cancer drug Tagrisso, having awarded the drug a conditional approval in February last year.

At the time, Tagrisso (AZD9291, osimertinib) was the new first medicine to win clearance under the European Commission’s expedited process, after Phase II studies showed an objective response rate of 66 percent and median progression-free survival of 9.7 months in adults with locally advanced or metastatic epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) carrying the T790M mutation.

Full approval for the drug came on the back of data from the Phase III AURA3 trial, which demonstrated statistically-significant improvements in progression-free survival (PFS) over standard platinum-based doublet chemotherapy in 419 patients with EGFR T790M-positive advanced NSCLC whose disease had progressed on or after EGFR TKI therapy.

PFS was 10.1 months in patients taking the drug compared to 4.4 months in the chemotherapy arm. Also, the objective response rate was 71 percent compared to 31 percent for chemotherapy. Among 144 patients with metastases to the central nervous system (CNS), PFS was 8.5 months versus 4.2 months.

Almost 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 to date, AZ said, highlighting the drug’s potential scope.

Tagrisso is a third generation, irreversible EGFR tyrosine kinase inhibitor designed to inhibit both EGFR sensitising and EGFR T790M resistance mutations and to have activity in the central nervous system (CNS).

"The full approval of Tagrisso in the EU is further evidence of our exciting progress in transforming the science of cancer care to deliver life-changing medicines to people most in need. Having demonstrated its superiority over chemotherapy in EGFR T790M mutation-positive non-small cell lung cancer, Tagrisso has the potential to become the new standard of care for patients with this difficult-to-treat form of lung cancer," said Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.

The drug is also being assessed in the adjuvant and metastatic first-line settings, including in patients with and without CNS metastases, in leptomeningeal metastases, and in combination with other treatments.