AstraZeneca’s Tagrisso Plus Chemo Secures EU Nod For Lung Cancer Breakthrough

The European Commission has granted AstraZeneca approval for Tagrisso (osimertinib) to be used in combination with chemotherapy for treating non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor mutations (EGFRm). This tyrosine kinase inhibitor, now approved for the first-line treatment, will be used alongside pemetrexed and platinum-based chemotherapy for patients whose tumors exhibit exon 19 deletions or exon 21 (L858R) mutations.

The approval is supported by favorable results from the Phase III FLAURA2 trial (NCT04035486). This trial, which included 557 patients, demonstrated that the combination of Tagrisso and chemotherapy reduced the risk of disease progression or death by 38% according to investigator assessment, compared to Tagrisso monotherapy, the current first-line global standard of care.

Moreover, patients treated with Tagrisso plus chemotherapy achieved a median progression-free survival (PFS) of 25.5 months, representing an 8.8-month increase compared to monotherapy. Progression-free survival (PFS) data from a blinded independent central review (BICR) aligned with the investigator's assessment, indicating a median PFS of 29.4 months for the combination therapy, which is a 9.5-month improvement over Tagrisso monotherapy.