The FDA has approved AstraZeneca’s new lung cancer drug Tagrisso, in a record two and half years from development, under the regulator’s accelerated approval pathway.
Tagrisso (AZD9291) is a once-daily tablet patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose cancer has progressed while they have been on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) therapy. The decision means that Tagrisso is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer.
It was approved under the FDA’s accelerated approval process based on the drug’s tumour response rate and duration of response. In the two Phase II studies on which the FDA based its decision, the overall objective response rate (ORR), a measure of how much a tumour shrank) was 59%.
AstraZeneca is currently running a Phase III study to confirm these results, as well as in the adjuvant setting and as a metastatic first-line treatment for metastatic forms of the disease, including in patients with brain metastases, as well as in combination with other compounds.
AstraZeneca chief executive Pascal Soriot says: “The FDA approval of TAGRISSO marks an important milestone for lung cancer patients who urgently need new treatment options. We have built on our heritage in this area and acted on the breakthrough clinical evidence to ensure this next-generation medicine reaches patients in record time. As we advance our comprehensive lung cancer portfolio, we have the opportunity to treat greater numbers of patients across all stages of this disease through precision medicines, immunotherapies and novel combinations.”
Pasi A Jänne, director of the Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute, and professor of medicine at Harvard Medical School, says: “In the AURA clinical studies, AZD9291 has demonstrated compelling early efficacy and tolerability in patients with EGFRm T790M metastatic non-small cell lung cancer. This treatment has the potential to become the standard of care for patients living with EGFRm T790M non-small cell lung cancer. The accelerated approval of AZD9291 highlights its clinical promise for a targeted group of patients and gives healthcare providers an important new option.”