Tuesday, April 16, 2024

Lung Cancer Chemotherapy Treatment Tagrisso Plus Receives US FDA Approval

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AstraZeneca’s groundbreaking development in lung cancer treatment, Tagrisso, coupled with chemotherapy, has received FDA approval for adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC), following a Priority Review. This landmark approval is grounded in the compelling findings of the FLAURA2 Phase III trial, which demonstrated that Tagrisso plus chemotherapy significantly reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy, currently the first-line global standard of care. The trial results, published in The New England Journal of Medicine, highlight a median progression-free survival (PFS) of 25.5 months for the combination therapy, marking an 8.8-month improvement over monotherapy.

The United States sees over 200,000 lung cancer diagnoses annually, with NSCLC accounting for 80-85% of these cases. Approximately 15% of these patients harbor an EGFR mutation, a target for Tagrisso’s therapeutic action. The FDA’s approval of this combination therapy offers hope, particularly for patients with advanced stages of this mutation-defined cancer subtype.

Pasi A. Jänne, MD, PhD, the principal investigator of the trial, and medical oncologist at Dana-Farber Cancer Institute, emphasized the significance of this approval in providing a critical new treatment option for patients with advanced EGFR-mutated NSCLC. Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Business Unit, echoed this sentiment, noting the nearly nine additional months of delayed disease progression established by this therapy as a new benchmark in first-line advanced treatment settings.

FLAURA2 Trial Shows Promising Results for Patients with Lung Cancer

Laurie Ambrose, President and CEO of GO2 for Lung Cancer, expressed excitement over the advancement of personalized treatment options for the lung cancer community, underscoring the collective goal of improved patient outcomes through timely and targeted therapy.

The FLAURA2 trial also conducted a prespecified exploratory analysis of patients with brain metastases at baseline, revealing that Tagrisso plus chemotherapy reduced the risk of central nervous system (CNS) disease progression or death by 42% compared to Tagrisso alone. With two years of follow-up, a significant majority of patients treated with the combination therapy had not experienced CNS disease progression or death, highlighting the treatment’s effectiveness in addressing metastatic challenges.

While overall survival (OS) results remain immature, the trial continues to evaluate OS as a critical secondary endpoint, with no observed detriment thus far. The safety profile of Tagrisso with chemotherapy was generally manageable, aligning with the established profiles of the individual medicines, despite a higher rate of adverse events due to chemotherapy-related side effects.

Lung Cancer

A New Standard in EGFRm NSCLC Treatment Following NCCN Guidelines Update

Following these promising results, osimertinib (Tagrisso) with chemotherapy has been recommended in the NCCN Clinical Practical Guidelines in Oncology as a category 1 regimen for patients with specific EGFR mutations. The US regulatory submission was part of Project Orbis, facilitating concurrent submission and review among international partners, with ongoing reviews by regulatory authorities in Australia, Canada, Switzerland, and several other countries.

Tagrisso’s approval in over 100 countries for various indications underscores its role as a cornerstone of EGFRm NSCLC treatment. AstraZeneca’s commitment to early lung cancer treatment continues with ongoing investigations in the neoadjuvant and early-stage adjuvant settings, promising further advancements in lung cancer care.


Resource: AstraZeneca, February 19, 2024

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