AstraZeneca PLC (NASDAQ:AZN) has confirmed that the FDA is set to review its supplemental new drug application (sNDA), with the intent of expanding the usage of its widely acclaimed drug, Tagrisso (osimertinib), as a combined therapy for advanced lung cancer.
The company’s application seeks approval for the use of Tagrisso in conjunction with chemotherapy for the initial treatment of adult patients dealing with locally advanced or metastatic non-small cell lung cancer (NSCLC) carrying EGFR mutations.
With the FDA having granted a priority review for the sNDA, a verdict from the regulatory authority is expected in the first quarter of 2024. Priority reviews are typically assigned to medications that hold the potential to address serious medical conditions or substantially enhance safety and efficacy.
Currently, Tagrisso is already sanctioned as a standalone therapy for EGFR-mutated NSCLC.
The basis for this recent sNDA was data collected from the phase III FLAURA-2 study. Findings from this study indicated that the combination of Tagrisso with chemotherapy resulted in a 38% reduction in the risk of disease progression or mortality. Furthermore, the data suggests that this combination extended the median progression-free survival by nearly nine and a half months.
In the year-to-date period, shares of AstraZeneca have not yielded any returns for investors, in contrast to the industry’s 8.5% upsurge.
Tagrisso has played a pivotal role in AstraZeneca’s revenue generation. In the first half of 2023, Tagrisso reported sales of $2.9 billion, a 12% increase year-over-year at constant exchange rates (“CER”). If granted approval for the new use, the drug is anticipated to witness further growth in sales by catering to a broader patient demographic.
AstraZeneca maintains a strong focus on reinforcing its portfolio of oncology products through expansions in the approved usage of existing drugs. In the first half of 2023, the company’s oncology division recorded sales of $8.3 billion, marking a 21% increase year-over-year at CER.
AstraZeneca’s oncology business is on an annual growth trajectory, currently exceeding $15 billion. Continuous label expansions for key cancer treatments are poised to further elevate sales in the near future.
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