AstraZeneca’s Tagrisso Plus Chemo Secures EU Nod For Lung Cancer Breakthrough
AstraZeneca's Tagrisso + chemo gains EU approval for first-line EGFRm NSCLC treatment; FLAURA2 trial success.
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.
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