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AstraZeneca's Tagrisso Recommended by EMA Committee in Adjuvant NSCLC

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, has recommended marketing authorization for AstraZeneca's osimertinib (Tagrisso) as an adjuvant treatment for early-stage, EGFR-mutated non-small cell lung cancer patients after surgical resection of their tumors.

The CHMP based its positive opinion on the results of the Phase III ADAURA trial, in which osimertinib reduced the risk of disease recurrence or death by 83 percent among patients with stage II to IIIa NSCLC compared to placebo, and by 80 percent in the overall trial population with stage Ib to IIIa disease. Patients had to have tumors with EGFR exon 19 deletions or exon 21 (L858R) mutations.

Typically, nearly half of stage Ib NSCLC patients and more than 75 percent of those with stage IIIa disease experience cancer recurrence within five years of diagnosis.  

"With no targeted treatment options currently available for early-stage lung cancer patients after surgery in the EU, recurrence rates remain unacceptably high," Dave Fredrickson, executive VP of AstraZeneca's oncology business unit, said in a statement. CHMP's recommendation also "reinforces the urgency to test all lung cancer patients for tumor mutations before making any treatment decisions to ensure that as many patients as possible can benefit from innovative therapies, like Tagrisso, when they become available," he added.

Regulators in a more than 15 countries, including in the US and China, have approved osimertinib in the adjuvant NSCLC setting based on the ADAURA data.