FDA grants priority review to AstraZeneca’s Tagrisso as an adjuvant for early-stage EGFR-mutated non-small cell lung cancer
pharmafile | October 20, 2020 | News story | Manufacturing and Production, Sales and Marketing | AstraZeneca, FDA, Tagrisso
The FDA has revealed its decision to grant Priority Review to AstraZeneca’s Tagrisso (osimertinib) as an adjuvant treatment of patients with early-stage (Stages 1B, 2 and 3A) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
The Priority status relates to patients who have previously undergone complete tumour resection with curative intent. As much as 70% of NSCLC patients do not receive diagnosis early enough to be eligible for curative surgery, and even in those that do commonly experience disease resurgence, with around half of Stage 1B and around 75% of Stage 3A patients experiencing resurgence within five years.
The US regulator gave the designation based on “unprecedented results” from a Phase 3 study supporting the efficacy of Tagrisso in generating “statistically significant and clinically meaningful improvement” in disease-free survival among participants with Stage 2 and 3A EGFRm NSCLC. The study was unblinded two years earlier than planned on the recommendation of an Independent Data Monitoring Committee in April this year.
“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,” explained Dave Fredrickson, Executive Vice President, Oncology Business Unit at AZ. “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.”
Tagrisso also secured Breakthrough Therapy Designation from the FDA in this indication back in July this year.
Matt Fellows
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