AstraZeneca’s (AZ) Tagrisso (osimertinib) has been approved by the European Commission (EC) as part of a combination treatment for a subset of advanced lung cancer patients.
The epidermal growth factor receptor-mutated (EGFR)-tyrosine kinase inhibitor has been authorised for use alongside pemetrexed and platinum-based chemotherapy as a first-line treatment for adults with locally advanced EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
The EC’s decision follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by results from the late-stage FLAURA2 trial, in which Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, the first-line global standard of care for these patients.
The combination was shown to extend median progression-free survival by 8.8 months compared to Tagrisso monotherapy, AZ said, adding that while overall survival data remained immature at the time of the interim analysis, a “a trend towards overall survival benefit” was observed with Tagrisso plus chemotherapy versus Tagrisso alone.
More than 450,000 people are diagnosed with lung cancer every year in Europe and NSCLC accounts for up to 85% of all diagnoses.
Up to 15% of NSCLC patients in Europe and the US have an EGFR mutation and, as a result, are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways driving tumour cell growth.
Dave Fredrickson, executive vice president, oncology business unit, AZ, said: “This approval reinforces Tagrisso as the backbone therapy in EGFR-mutated lung cancer either as monotherapy or in combination with chemotherapy.
“This is especially important for those with more aggressive disease, including patients whose cancer has spread to the brain and those with L858R mutations.”
Tagrisso is already approved as monotherapy in more than 100 countries, with approved indications including for the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and for the adjuvant treatment of early-stage EGFRm NSCLC.
The latest approval comes just days after AstraZeneca’s anti-PDL1 antibody Imfinzi (durvalumab) and PARP inhibitor Lynparza (olaparib) were recommended by the Committee for Medicinal Products for Human Use to treat a subset of endometrial cancer patients.