AstraZeneca’s Tagrisso gains FDA priority review in unresectable EGFRm lung cancer
10 Jun 2024
AstraZeneca announced Monday that the FDA granted priority review to an application seeking approval of Tagrisso (osimertinib) for the treatment of adults with unresectable, stage III EGFR-mutated non-small-cell lung cancer (NSCLC) following chemoradiotherapy. The agency is expected to decide on the filing, which is specifically for patients with tumours harbouring exon 19 deletions or exon 21 (L858R) mutations, in the fourth quarter.
“Priority review of Tagrisso in this early-stage curative setting is important for patients who currently have no targeted treatments available,” said Susan Galbraith, EVP of oncology R&D at AstraZeneca. If approved, the third-generation EGFR tyrosine kinase inhibitor could emerge “as a potential new standard of care” for these patients, she added..
The application is supported by findings from the Phase III LAURA study, which top-lined in February, with detailed results presented at the recent American Society of Clinical Oncology (ASCO) annual meeting. Data showed that Tagrisso met the trial’s main goal, cutting the risk of disease progression or death by 84% compared with placebo. Median progression-free survival was 39.1 months in the Tagrisso group versus 5.6 months for placebo, with the benefit consistent across prespecified subgroups. Furthermore, a positive trend on overall survival was observed in favour of AstraZeneca’s drug.
FirstWord is currently fielding a poll to physicians in the US and Europe about the impact of the LAURA data on their use of Tagrisso. See here for more: Physician Views Preview: Will new data move AstraZeneca’s Tagrisso into a new lung cancer setting?
Tagrisso is currently approved in the US for the first-line treatment of metastatic EGFR-mutated NSCLC and as adjuvant therapy for resectable NSCLC following surgery. Within NSCLC, the drug is also being studied in the neoadjuvant and early-stage adjuvant resectable settings in the late-stage NeoADAURA and ADAURA2 studies, respectively.
Tagrisso stood at the top of the company’s oncology portfolio last year, achieving nearly $5.8 billion in global sales. Jefferies analysts project revenue from the product will reach $7.4 billion in 2028, peaking at $7.7 billion.
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