The FDA has granted the Prescription Drug User Fee Act (PDUFA) date to announce its regulatory decision, during the first quarter of 2021

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AstraZeneca New Cambridge R&D centre and global headquarters aerial view. (Credit: AstraZeneca.)

AstraZeneca has secured the US Food and Drug Administration (FDA) Priority Review for Tagrisso (osimertinib) to treat a type of early-stage non-small cell lung cancer (NSCLC).

The US regulatory agency has accepted the company’s supplemental New Drug Application (sNDA) for Tagrisso as adjuvant treatment for early-stage epidermal growth factor receptor-mutated (EGFRm) NSCLC, after complete tumour resection with curative intent.

The FDA has granted the Prescription Drug User Fee Act (PDUFA) date, to announce its regulatory decision, during the first quarter of 2021.

Tagrisso is an irreversible EGFR-TKI, capable of acting against the central nervous system metastases, and has received the FDA Breakthrough Therapy Designation in July this year.

AstraZeneca oncology business unit executive vice president Dave Fredrickson said: “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.

“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.”

AstraZeneca’s Tagrisso sNDA is based on Phase 3 ADAURA trial results

The British drugmaker has filed the tagrisso sNDA, based on results from the Phase 3 ADAURA trial, a randomised, double-blinded, global, placebo-controlled study.

The study enrolled 682 patients with early-stage EGFRm NSCLC, after complete tumour resection and adjuvant chemotherapy, in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East.

In the late-stage trial, treatment using Tagrisso showed statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with EGFRm NSCLC

Also, the drug has shown positive results in the overall trial population of patients with Stage IB-IIIA disease, which is a key secondary endpoint in the ADAURA trial.

Tagrisso 40mg and 80mg once-daily oral tablets have been approved in the US, Japan, China, the EU and other countries for the treatment of EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC.