Press Release

July 30, 2020
2 min read

FDA grants breakthrough therapy designation to Tagrisso for lung cancer subset


Press Release

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The FDA granted breakthrough therapy designation to osimertinib for adjuvant treatment of certain patients with early-stage non-small cell lung cancer, according to the agent’s manufacturer.

The designation applies to use of osimertinib (Tagrisso, AstraZeneca) by patients with stage IB to stage IIIA EGFR-mutated NSCLC after complete tumor resection with curative intent.

Approximately one-third of patients with NSCLC present with early-stage disease, defined as stage IB through stage IIIA. Surgery is the primary treatment for these patients. Adjuvant chemotherapy is standard for those with stage II or stage III disease, as well as for select patients with stage IB disease.

Despite these treatments, 5-year recurrence rates range from 45% for patients with stage IB disease to 76% for those with stage III disease.

Osimertinib — a third-generation, irreversible EGFR-directed tyrosine kinase inhibitor — is approved in the United States for first-line treatment of patients with metastatic NSCLC whose tumors harbor EGFR mutations.

The randomized phase 3 ADAURA trial evaluated the efficacy and safety of adjuvant osimertinib vs. placebo for 682 patients with stage IB to stage IIIA EGFR-mutated NSCLC who underwent complete tumor resection and — if indicated — adjuvant chemotherapy.

Researchers randomly assigned 339 patients to osimertinib dosed at 80 mg once daily. The other 343 patients received placebo. Treatment continued for up to 3 years.

Investigator-assessed DFS among patients with stage II or stage IIIA disease served as the primary endpoint. Secondary endpoints included DFS in the entire study population, OS and safety.

Results of an unplanned interim analysis presented during the ASCO20 Virtual Scientific Program showed osimertinib significantly improved DFS among patients with stage II to stage IIIA disease (median, not reached vs. 20.4 months; HR = 0.17; 95% CI, 0.12-0.23).

Osimertinib also conferred a statistically significant DFS benefit in the overall study population (median, not reached vs. 28.1 months; HR = 0.21; 95% CI, 0.16-0.28).

José Baselga, MD, PhD
José Baselga

“Patients with early-stage EGFR-mutated lung cancer often experience recurrence even after successful surgery and adjuvant chemotherapy, yet there are currently no approved targeted treatments to improve outcomes,” José Baselga, MD, PhD, executive vice president for oncology research and development with AstraZeneca, said in a company-issued press release. “The phase 3 ADAURA trial with Tagrisso demonstrated an unprecedented level of clinical benefit in these patients, and we are working closely with the FDA to deliver this potentially curative treatment to patients as quickly as possible.”