AstraZeneca PLC (NASDAQ:AZN) has revealed that the FDA is prioritizing the review of its supplemental new drug application (sNDA) for an expanded use of its widely successful drug, Tagrisso (osimertinib), as part of a combination therapy for advanced lung cancer.

The company’s objective is to secure approval for the utilization of Tagrisso, combined with chemotherapy, as a first-line treatment for adult patients dealing with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors harbor EGFR mutations.

With the FDA granting a priority review to this sNDA, a verdict from the regulatory authority is anticipated in the first quarter of 2024.

The FDA typically designates priority review to drugs with the potential to treat severe conditions, promising considerable enhancements in safety or efficacy if granted approval.

Currently, Tagrisso is already sanctioned as a monotherapy for the treatment of EGFR-mutated NSCLC.

The most recent sNDA is grounded in data from the phase III FLAURA-2 study.

Data stemming from the study demonstrated that the Tagrisso and chemotherapy combination curtailed the risk of disease progression or mortality by 38%. Moreover, the study’s results indicated that this combination therapy extended median progression-free survival by nearly nine and a half months.

In contrast to the industry’s growth of 8.5%, AstraZeneca’s shares have not yielded returns to investors year-to-date.

Tagrisso has notably fueled AstraZeneca’s revenues, raking in sales of $2.9 billion in the initial half of 2023. This signifies a 12% increase year-over-year at constant exchange rates (CER). If the drug secures approval for this new application, its sales are expected to climb further as it caters to a more extensive patient demographic.

AstraZeneca is unwavering in its commitment to bolster its oncology product range through the expansion of existing product labels. The company’s oncology division recorded sales of $8.3 billion in H1 2023, marking a 21% year-over-year increase at CER.

AstraZeneca’s oncology division is currently running at an annual rate of almost $15 billion. Sustained label extensions for pivotal cancer medications are poised to stimulate future sales growth.

Featured Image: Unsplash ©  Mika Baumeiste

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