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

AstraZeneca's (AZN.L, AZN) Tagrisso (osimertinib), combined with pemetrexed and platinum-based chemotherapy, has received a recommendation for approval in the European Union as a first-line treatment for adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) exhibiting exon 19 deletions or exon 21 (L858R) mutations.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) based its positive recommendation on data from the FLAURA2 Phase III trial. This trial demonstrated that Tagrisso, when used in conjunction with chemotherapy, extended the median progression-free survival by nearly nine months compared to the standard treatment.

Currently, Tagrisso is approved as a monotherapy in over 100 countries, including the United States, the European Union, China, and Japan. Its approved indications encompass first-line treatment for patients with locally advanced or metastatic EGFRm NSCLC, treatment for locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and adjuvant treatment for early-stage EGFRm NSCLC.

Additionally, the combination of Tagrisso and chemotherapy is approved in the United States and several other countries for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC.