AstraZeneca’s (AZ) Tagrisso (osimertinib) has been approved by the US Food and Drug Administration (FDA) in combination with chemotherapy to treat a subset of advanced lung cancer patients.

The epidermal growth factor receptor-mutated (EGFR)-tyrosine kinase inhibitor has specifically been authorised for use alongside chemotherapy in adults with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).

An estimated 200,000 people in the US are diagnosed with lung cancer each year and NSCLC accounts for up to 85% of all lung cancer cases.

Approximately 15% of NSCLC patients in the US have an EGFRm, with this population “particularly sensitive” to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways that drive the growth of tumour cells, AZ said.

The FDA’s decision was supported by positive results from the late-stage FLAURA2 trial, which randomised more than 500 patients with locally advanced or metastatic EGFRm NSCLC to receive the Tagrisso/chemotherapy combination or Tagrisso alone.

The results showed that the combination reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, which is currently the first-line global standard of care for these patients.

The combination was shown to extend median progression-free survival by 8.8 months and improve progression-free survival by 9.5 months compared to Tagrisso monotherapy, AZ said.

Dave Fredrickson, executive vice president, oncology business unit at AZ, said: “This important new treatment option can delay disease progression by nearly nine additional months, establishing a new benchmark with the longest reported progression-free survival benefit in the first-line advanced setting.”

Tagrisso is already approved as monotherapy in more than 100 countries, with indications including for first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and for adjuvant treatment of early-stage EGFRm NSCLC.

Commenting on the latest approval, Laurie Ambrose, president and chief executive officer, GO2 for Lung Cancer, said: “We are so excited to see this continued progress advancing more personalised treatment options for our community.

"The more we can target the right treatments for the right people at the right time, the better outcomes will be for our community – a goal we all collectively share.”

https://www.pmlive.com/pharma_news/astrazenecas_tagrisso_combination_approved_by_fda_for_advanced_lung_cancer_1508891