AstraZeneca's Tagrisso Gets EU Approval For Unresectable EGFR-mutated Lung Cancer

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(RTTNews) - British drug maker AstraZeneca Plc (AZN.L, AZN) announced Monday that the European Commission has approved Tagrisso (osimertinib) to treat adult patients with locally advanced, unresectable non-small cell lung cancer or NSCLC in the European Union.

The company noted that Tagrisso is the first and only EGFR inhibitor and targeted treatment approved in the EU in unresectable NSCLC.

The approval is for the treatment of NSCLC patients, whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. Their disease has not progressed during or following platinum-based chemoradiation therapy (CRT).

The EU approval follows the positive opinion of the Committee for Medicinal Products for Human Use or CHMP in mid November and is based on results from the LAURA Phase III trial, which showed Tagrisso extended median progression-free survival to more than three years.

The trial results were published in The New England Journal of Medicine.

In the trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso, compared to 5.6 months for placebo.

The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile, while no new safety concerns were identified.

The trial, which showed that overall survival or OS results remain immature, is continuing to assess OS as a secondary endpoint.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said, "Tagrisso is now the first and only EGFR inhibitor and targeted treatment approved in the EU for locally advanced, unresectable lung cancer, providing a new standard of care to patients who have historically experienced early progression after chemoradiation therapy. The powerful results from the LAURA trial show Tagrisso improves outcomes for patients in the unresectable setting, reinforces the importance of timely EGFR testing and solidifies Tagrisso as the backbone therapy in EGFR-mutated non-small cell lung cancer."

AstraZeneca noted that Tagrisso based on the LAURA trial recent received approvals in the US, Switzerland, South Korea and Australia. Regulatory applications are also currently under review in China, Japan and several other countries.

Tagrisso is approved as monotherapy in more than 100 countries including in the US, EU, China and Japan for different indications of NSCLC. It is also approved in combination with chemotherapy in the US, China and several other countries for 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.

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