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TAGRISSO® (Osimertinib) Granted Priority Review for Stage III EGFR-Mutated Lung Cancer Treatment in the US

Tuesday, June 11, 2024

AstraZeneca has submitted a supplemental New Drug Application (sNDA) for TAGRISSO® (osimertinib), which has been accepted for Priority Review by the FDA. This application seeks approval for TAGRISSO in treating adults with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) following chemoradiotherapy (CRT). Should it receive approval, TAGRISSO will be indicated for patients with tumors showing exon 19 deletions or exon 21 (L858R) mutations.

The FDA's Priority Review designation is typically granted to treatments that demonstrate significant enhancements in safety or efficacy compared to existing options, thereby providing potential benefits in managing serious conditions or improving patient adherence. The decision on this application is expected in the fourth quarter of 2024.

Recently, TAGRISSO was also granted Breakthrough Therapy Designation by the FDA, an initiative designed to expedite the development and review of drugs that target serious conditions and meet unmet medical needs.

Lung cancer, particularly NSCLC, is a major cause of cancer-related deaths. Approximately 15% of NSCLC patients in the US have EGFR mutations, and about 20% of newly diagnosed cases are considered unresectable.

Susan Galbraith, AstraZeneca’s Executive Vice President of Oncology R&D, highlighted the importance of this Priority Review, especially for patients who currently lack targeted treatment options. AstraZeneca aims to work closely with the FDA to quickly make TAGRISSO available, potentially setting a new standard in care.

The sNDA is supported by findings from the LAURA Phase III clinical trial, which were presented at the 2024 ASCO Annual Meeting and published in The New England Journal of Medicine. The trial showed that TAGRISSO decreased the risk of disease progression or death by 84% compared to a placebo, with TAGRISSO-treated patients experiencing a median progression-free survival of 39.1 months versus 5.6 months for the placebo group. This benefit was consistent across different patient subgroups.

The safety profile of TAGRISSO remains consistent with previously known data, with no new safety issues reported.

TAGRISSO is already approved in over 100 countries for various indications in EGFRm NSCLC, including its use in combination with chemotherapy as a first-line treatment. Ongoing and planned clinical trials are exploring its effectiveness in additional settings.

Key Safety Information:

  • TAGRISSO has no known contraindications.
  • ILD or pneumonitis has been reported in 4% of patients, with 0.4% of cases proving fatal.
  • Some patients exhibit QT interval prolongation, necessitating monitoring.
  • Cardiomyopathy and other cardiac effects have been documented, requiring cardiac monitoring.
  • Eye conditions such as keratitis have occurred.
  • Postmarketing reports have indicated severe skin reactions, including erythema multiforme major and Stevens-Johnson syndrome.
  • Aplastic anemia and other significant adverse reactions have been observed.

TAGRISSO is a third-generation irreversible EGFR-tyrosine kinase inhibitor that has shown efficacy in treating EGFRm NSCLC across various stages of the disease. AstraZeneca continues to investigate its potential in early-stage and combination therapy settings.

AstraZeneca is dedicated to advancing cancer treatment through innovation and collaboration, striving to bring effective therapies to patients with lung cancer.

 

Source: businesswire.com

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