AstraZeneca gets FDA nod for Tagrisso in certain lung cancers

AstraZeneca announced on Tuesday that ‘Tagrisso’, or osimertinib, has received acceptance for its supplemental New Drug Application (sNDA), and has also been granted Priority Review in the United States, for the adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), after complete tumour resection with curative intent.

The FTSE 100 pharmaceuticals giant said that, while up to 30% of all patients with NSCLC could be diagnosed early enough to have potentially curative surgery, disease recurrence was still common in early-stage disease.

It said nearly half of patients diagnosed in stage IB, and more than three-quarters of patients diagnosed in stage IIIA, experienced recurrence within five years.

The company explained that the Food and Drug Administration (FDA) grants Priority Review to applications for medicines that offer “significant improvements” over available options, by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

It said the Prescription Drug User Fee Act date, which is the FDA action date for their regulatory decision, would be during the first quarter of 2021.

“Patients with early-stage EGFR-mutated lung cancer are still at considerable risk of recurrence after surgery and adjuvant chemotherapy, and new targeted treatment options are critical to improving outcomes for these patients,” said Dave Fredrickson, executive vice-president of AstraZeneca’s oncology business unit.

“This expedited review underscores the unprecedented disease-free survival benefit Tagrisso brings to patients in the adjuvant setting, and we will continue working with the FDA to provide this practice-changing treatment to patients as quickly as possible."

The company said the sNDA was based on results from the ‘ADAURA’ phase 3 trial, which showed that Tagrisso demonstrated a “statistically significant and clinically meaningful” improvement in disease-free survival in the primary analysis population of patients with stage II and stage IIIA EGFRm NSCLC, and also in the overall trial population of patients with stage IB-IIIA disease, which was a key secondary endpoint.

In April, an independent data monitoring committee recommended the trial be unblinded two years early, based on its determination of “overwhelming” efficacy.

Investigators and patients were still participating in the trial, and remained blinded to treatment.

The results from the ADAURA trial were presented during the plenary session of the American Society of Clinical Oncology Virtual Scientific Program in May, and were recently published in the New England Journal of Medicine .

AstraZeneca noted that Tagrisso received Breakthrough Therapy Designation in this setting in July.

Tagrisso was approved for both the first-line treatment of patients with locally-advanced or metastatic EGFRm NSCLC, and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the European Union, and a number of other countries.

At 0854 BST, shares in AstraZeneca were up 0.83% at 8,176p.