India, May 27 -- British drug major AstraZeneca Plc. (AZN.L,AZN) announced Tuesday that its Imfinzi (durvalumab) has been recommended for approval in the European Union to treat muscle-invasive bladder cancer or MIBC.
The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency made the recommendation for the treatment of adult patients with 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).
Imfinzi has been recommended for approval in the EU as first and only perioperative immunotherapy for MIBC.
The recommendation is based on NIAGARA Phase III trial results w...