FDA approves AstraZeneca’s Imfinzi-BCG combination for NMIBC therapy

AstraZeneca has secured FDA approval for Imfinzi in combination with BCG induction and maintenance therapy for adults with BCG-naïve, high-risk NMIBC. The approval relies on positive data from the POTOMAC Phase III trial. In the POTOMAC trial, one year of Imfinzi plus BCG reduced disease recurrence, progression or death risk by 32%. Credit: Sai Thaw Kyar / Shutterstock.com. AstraZeneca has received approval from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy for adult patients with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC). This marks the first approved immunotherapy combination…

Source: Pharmaceutical Technology