LONDON (dpa-AFX) - AstraZeneca's (AZN.L, AZN) Tagrisso (osimertinib) with
the addition of pemetrexed and platinum-based chemotherapy has been recommended
for approval in the European Union for 1st-line treatment of adult patients
with locally advanced or metastatic epidermal growth factor receptor-mutated
(EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions
or exon 21 (L858R) mutations.

The Committee for Medicinal Products for Human Use (CHMP) of the European
Medicines Agency (EMA) based its positive opinion on the results from the
FLAURA2 Phase III trial. The results showed Tagrisso plus chemotherapy extended
median progression-free survival by nearly 9 months compared to standard of
care.

Tagrisso is approved as monotherapy in more than 100 countries including in the
US, EU, China and Japan. Approved indications include for 1st-line treatment of
patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or
metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment of
early-stage EGFRm NSCLC.

Tagrisso with the addition of chemotherapy is also approved in the US and
several other countries for the 1st-line treatment of patients with locally
advanced or metastatic EGFRm NSCLC.



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