CHMP Recommends Approval Of AstraZeneca's Tagrisso Combo For EGFR-Mutated Advanced Lung Cancer

(RTTNews) - 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.