EU recommends AstraZeneca bladder cancer treatment for approval

(Sharecast News) - EU regulators have recommended AstraZeneca's Imfinzi for approval in the treatment muscle-invasive bladder cancer (MIBC). The recommendation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency means that Imfinzi could be the first and only perioperative immunotherapy for adults with MIBC on the market.

Imfinzi, otherwise known as durvalumab, has been recommended for the treatment of resectable MIBC in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as monotherapy adjuvant treatment after radical cystectomy (surgery to remove the bladder), AstraZeneca said in a statement on Tuesday.

The recommendation was based on the Niagara Phase III trial, which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen compared with neoadjuvant chemotherapy alone.

According to Michiel Van der Heijden, the investigator of the Niagara trial, half of patients with MIBC will see the disease recur despite treatment with neoadjuvant chemotherapy and surgery to remove the bladder.

"This recommendation for the durvalumab-based perioperative regimen brings us closer to providing an important new treatment option that has demonstrated a significant survival benefit, with the potential to transform the treatment approach for patients across Europe," he said.