IN BRIEF: AstraZeneca gets FDA panel nod for Truqap in prostate cancer

AstraZeneca PLC - Cambridge, England-based pharmaceutical maker - Says the US Food & Drug Administration's Oncologic Drugs Advisory Committee recommended the benefit–risk profile of Truqap when used with abiraterone and hormone‑lowering therapy for PTen‑deficient metastatic hormone‑sensitive prostate cancer. AstraZeneca says the recommendation follows late‑stage trial results showing the combination helps delay disease progression. The company adds it is the first targeted treatment to show benefit in this form of the disease and notes the decision follows the FDA's earlier acceptance of its application. Truqap is a targeted treatment designed to block a growth pathway used by cancer cells.

"The committee's recognition of the unmet need in patients with PTEN-deficiency and of the benefit seen with the Truqap combination verifies its potential to address this significant need and optimise outcomes for patients. We are committed to working closely with the FDA to bring the first and only targeted treatment option to the one in four patients with this form of metastatic hormone-sensitive prostate cancer," says Susan Galbraith, executive vice president, Oncology Haematology Research & Development.

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By Judy Amaca, Alliance News reporter Asia-Pacific

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