(AOF) – AstraZeneca announces that its product Tagrisso (osimertinib) combined with chemotherapy has been approved in the United States for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFRm) mutation. The Swedish-British laboratory specifies that this approval follows a priority review by the FDA (Food and Drug Administration) based on the results of the phase III Flaura2 trial published in the “New England Journal of Medicine”.
AstraZeneca adds this Monday that high-level positive results from the Phase III Laura trial showed that Tagrisso demonstrated a statistically significant and clinically highly meaningful improvement in progression-free survival (PFS) in patients with a mutation unresectable stage III epidermal growth factor receptor (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) compared to placebo after CRT.
Astrazeneca also announces that its Biologics License Application (BLA) filed with its Japanese partner Daiichi Sankyo for datopotamab deruxtecan (Dato-DXd) has been accepted in the United States for the treatment of adult patients with lung cancer. Locally advanced or metastatic non-squamous cell non-small cell (NSCLC) who have previously received systemic treatment.
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Oncology, priority of pharmaceutical giants
Sanofi’s stock market disappointment recorded at the end of October 2023 underlines the new direction for the group, which has now set oncology as its number 1 priority. Efforts in this segment, where therapies are advancing the fastest, notably involve investments in R&D which weigh on profitability. Sanofi therefore announced a drop in its earnings per share in 2024 and the abandonment of its objective of an operating margin of 32% in 2025. Merck has just unveiled a new alliance. It will pay up to $22 billion to the Japanese group Daiichi Sankyo as part of a partnership on experimental cancer treatments. While some experts estimate that the United States represents nearly half of global oncology spending (drugs and treatments), or $196 billion in 2022, Chinese spending in this area has more than doubled in five years, going from 5 to 11.8 billion dollars.