TAGRISSO® (osimertinib) Gets Priority Review in US for Unresectable Stage III EGFR-Mutated Lung Cancer

AstraZeneca has announced that their supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib) has been accepted and granted Priority Review status by the U.S. Food and Drug Administration (FDA). This application pertains to the use of TAGRISSO for treating adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) following chemoradiotherapy (CRT). If approved, this will allow TAGRISSO to be used specifically for tumors with exon 19 deletions or exon 21 (L858R) mutations.

The FDA's Priority Review designation is awarded to drugs that, if approved, would significantly improve the treatment landscape by providing better safety or effectiveness, preventing serious conditions, or enhancing patient adherence to treatment protocols. The target date for the FDA's decision is expected in the fourth quarter of 2024.

In addition to the Priority Review status, TAGRISSO has also been granted Breakthrough Therapy Designation (BTD) by the FDA for this specific setting. The BTD is designed to expedite the development and review processes for drugs intended to treat serious conditions where there is a substantial unmet medical need.

Lung cancer remains a significant health challenge in the United States, with nearly 200,000 new cases diagnosed each year. Of these, 80-85% are identified as NSCLC, the most common form of lung cancer, and approximately 15% of NSCLC patients have EGFR mutations. A considerable portion of these patients, about 20%, have unresectable tumors at the time of diagnosis.

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the importance of the Priority Review status for TAGRISSO, highlighting that no targeted treatments currently exist for patients in this early-stage, curative setting. She expressed optimism about working closely with the FDA to bring TAGRISSO to patients as swiftly as possible, potentially establishing it as a new standard of care.

The sNDA submission was supported by data from the LAURA Phase III trial, results of which were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in The New England Journal of Medicine. In this trial, TAGRISSO significantly reduced the risk of disease progression or death by 84% compared to a placebo. The median progression-free survival (PFS) for patients treated with TAGRISSO was 39.1 months versus 5.6 months for those on placebo. This benefit in PFS was consistent across various subgroups, including different sexes, races, types of EGFR mutations, ages, smoking histories, and previous CRT treatments.

While overall survival (OS) data showed a positive trend for TAGRISSO, the data were not mature enough at the time of this analysis, and the trial will continue to monitor OS as a secondary endpoint. The safety profile of TAGRISSO was consistent with previous studies, and no new safety concerns were noted.

TAGRISSO is already approved as monotherapy in over 100 countries, including the US, EU, China, and Japan, for various indications such as first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, and adjuvant treatment of early-stage EGFRm NSCLC. The drug is also approved in combination with chemotherapy for first-line treatment in several countries.

AstraZeneca's ongoing commitment to lung cancer treatment includes extensive research and multiple clinical trials aimed at addressing various stages of the disease and exploring potential new treatment combinations. The company is also involved in collaborative efforts to accelerate innovation and improve patient outcomes in lung cancer.