Truqap prostate cancer withdrawal: AstraZeneca pulls EU bid

The Truqap prostate cancer withdrawal ends AstraZeneca’s request to extend the drug’s marketing authorisation to newly diagnosed prostate cancer. AstraZeneca AB withdrew the application on 16 September 2026, and the European Medicines Agency (EMA) dated its notice 16 October 2026.

The application covered metastatic, PTEN-deficient prostate cancer that still responds to hormone treatment. Truqap (capivasertib) would have been used with abiraterone, prednisolone or prednisone, plus background hormonal therapy. The main study enrolled 1,012 patients, who received either Truqap or placebo alongside standard treatment.

Truqap prostate cancer withdrawal: the Agency’s concerns

The study showed a statistically significant improvement in the time before scans showed the cancer was getting worse. The Agency judged that improvement small and not clearly clinically meaningful. The data did not establish whether Truqap helped patients live longer overall. Serious side effects were more frequent with Truqap than with placebo, and more patients stopped treatment because of side effects.

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At the time of withdrawal, the EMA’s provisional opinion was that Truqap could not have been authorised for this use. Its benefits, in the Agency’s view, did not outweigh its risks. AstraZeneca told the Agency it withdrew because the Agency would not be able to conclude that benefits outweighed risks on the available data.

Why it matters

The Agency did not treat a statistically significant result as enough on its own. It weighed the size of the gain, the missing overall survival data and the higher rate of serious side effects together. Truqap remains authorised for breast cancer, and AstraZeneca told the Agency there are no consequences for patients in clinical trials.

Source: EMA variation notice on Truqap (capivasertib), EMA/227813/2026