FDA Sets Review Date for Tagrisso for Specific Lung Cancer Mutations


Tagrisso, which is already available to treat patients with non-small cell lung cancer and EGFR mutations, is being reviewed by the FDA for patients with this cancer and exon 19 deletions or exon 21 mutations.

The FDA has granted priority review for AstraZeneca’s supplemental new drug application for Tagrisso (osimertinib) to treat adult patients with Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy. If approved, Tagrisso will be indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 (L858R) mutations and whose tumors are not capable of being removed.

The Prescription Drug User Fee Act date is anticipated during the fourth quarter of 2024.

This year, there will be about 234,580 new cases of lung cancer and about 125,070 deaths from lung cancer, according to the American Cancer Society. Non-small cell lung cancer is the most common type of lung cancer. About 15% of NSCLC patients in the United States have EGFR mutations.

Tagrisso is already available to treat early stage EGFR+ NSCLC after surgery and for late-stage, metastatic EGFR+ NSCLC. It has a cost of $18,034 for 30 tablets, according to Drugs.com. Some patients with commercial insurance may be eligible to $0 per month copay, with a limit of $26,000 per year. Other patients who receive Tagrisso through a specialty pharmacy can receive Tagrisso for a $50 a month copay.

Susan Galbraith

Susan Galbraith

“Tagrisso continues to serve patients as a backbone therapy in EGFR-mutated lung cancer, extending progression-free survival in the LAURA trial by more than three years and reinforcing the importance of testing for EGFR mutations at the time of diagnosis,” Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said in a news release.

The sNDA is based on data from the LAURA phase 3 trial, which were recently presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine.

The LAURA trial enrolled patients at least 18 years of age with locally advanced, unresectable stage III NSCLC harboring EGFR exon 19 deletions or exon 21 L858R mutations. In the trial, Tagrisso reduced the risk of disease progression or death by 84% compared with placebo. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo. Overall survival (OS) data showed a favorable trend for Tagrisso, although data were not mature at the time of this analysis. The trial will continue to assess overall survival as a secondary endpoint.

Safety results and discontinuation rates due to adverse events were consistent with its known profile and no new safety concerns were identified. In the LAURA trial, serious adverse events were reported in 38% of patients in the Tagrisso arm compared with 15% in the placebo arm. Adverse events that led to discontinuation, dose reduction, and dose interruption in 13%, 8%, and 56% of patients in the Tagrisso arm, respectively.

The most common any-grade adverse events were radiation pneumonitis, diarrhea, rash, COVID-19, paronychia, cough, decreased appetite, dry skin, itching, stomatitis, decreased white blood cell count, pneumonia, anemia, and musculoskeletal chest pain.

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