This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use and is based on the results of the FLAURA2 Phase III trial.
The trial demonstrated that the combination therapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, which is the current first-line global standard of care.
The median progression-free survival (PFS) for patients receiving the combination therapy was 25.5 months, an 8.8-month improvement over monotherapy.
Blinded independent central review (BICR) confirmed the PFS results, showing a 29.4-month median PFS for the combination therapy, 9.5 months longer than the monotherapy.
Additionally, a prespecified exploratory analysis indicated that the combination therapy reduced the risk of central nervous system (CNS) disease progression or death by 42% in patients with brain metastases at baseline.
After two years of follow-up, 74% of patients treated with the combination therapy had not experienced CNS disease progression or death, compared to 54% with monotherapy.
While overall survival (OS) results are not yet mature, a trend towards an OS benefit with the combination therapy was observed.
AstraZeneca executive vice president of Oncology Business Unit Dave Fredrickson, stated, “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.”
Annually, there are an estimated 2.4 million people diagnosed with lung cancer across the world, with 80-85% of them diagnosed with NSCLC, which is considered as the most common form of lung cancer.
Tagrisso is approved as monotherapy in over 110 countries including in the US, EU, China and Japan.
The indications for which it is approved include for first-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.
The combination therapy is also approved in the US, China, Japan, and several other countries for the first line treatment of patients suffering with locally advanced or metastatic EGFRm NSCLC.
Furthermore, Tagrisso is under review by global regulatory authorities for patients with unresectable, Stage III EGFRm NSCLC based on the LAURA Phase III trial.