AstraZeneca has won approval from the European Commission for Tagrisso (osimertinib) in combination with chemotherapy for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor mutations (EGFRm) in adults.

The tyrosine kinase inhibitor has been approved alongside pemetrexed and platinum-based chemotherapy for the first-line treatment of adults whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

Approval is based on positive data from the Phase III FLAURA2 trial (NCT04035486). The trial enrolled 557 patients, showing that Tagrisso and chemotherapy reduced the risk of disease progression or death by 38% by investigator assessment compared to Tagrisso monotherapy, which is the first-line global standard of care.

Additionally, median progression-free survival was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus monotherapy.

Progression-free survival (PFS) results from a blinded independent central review (BICR) were consistent with the results by investigator assessment, showing 29.4 months median PFS with Tagrisso plus chemotherapy, a 9.5-month improvement over Tagrisso monotherapy.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approving Tagrisso last month. The drug earned AstraZeneca $5.8bn in sales last year, as per the company’s financials. According to GlobalData’s Pharma Intelligence Centre, Tagrisso is forecast to generate $7.4bn in 2030.

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Currently, AstraZeneca’s Imfinzi (durvalumab) is the standard of care for patients with stage III EGFRm NSCLC, but studies have shown that administering immunotherapy to patients with EGFRm is associated with very low response rates. 

In the announcement accompanying the approval, AstraZeneca oncology business executive vice president Dave Fredrickson 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 combined with chemotherapy is already approved for the first-line treatment of locally advanced or metastatic EGFRm NSCLC in the USA, China, Japan, and other countries. It is also approved as monotherapy in more than 110 countries, including in the USA, EU, China, and Japan, for locally advanced or metastatic EGFRm NSCLC, EGFR T790m positive NSCLC, and as an adjuvant therapy for early-stage EGFRm NSCLC. 

Note: The stanfirst has been updated to reflect the correct PFS data.