AstraZeneca's Imfinzi approved in US as first immunotherapy combo for high-risk bladder cancer
The US Food and Drug Administration (FDA) has approved AstraZeneca's Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) for adults with high-risk non-muscle-invasive bladder cancer (NMIBC). This marks the first immunotherapy combination for this specific patient group.
AstraZeneca announced that the US Food and Drug Administration (FDA) has approved Imfinzi (durvalumab) in combination with Bacillus Calmette-Guérin (BCG) induction and maintenance therapy. This approval is for adult patients diagnosed with BCG-naïve, high-risk non-muscle-invasive bladder cancer (NMIBC), establishing it as the first immunotherapy combination treatment for this condition.
The FDA's decision is based on findings from the POTOMAC Phase III clinical trial. The trial demonstrated that adding Imfinzi to BCG induction and maintenance therapy reduced the risk of disease recurrence, progression, or death by 32% over one year compared to BCG alone. This substantial reduction in risk is a notable advancement for patients with a condition known for high recurrence rates.
High-risk NMIBC is characterized by significant challenges, with up to 80% of patients experiencing recurrence within five years despite standard treatment involving tumor resection followed by BCG. The approval of the Imfinzi combination offers a new therapeutic option, addressing a long-standing need for novel treatments in this early stage of bladder cancer.
The safety profile of the Imfinzi-BCG combination was found to be consistent with the known profiles of the individual medicines, with no new safety concerns identified. AstraZeneca is pursuing regulatory reviews of the POTOMAC trial data in other regions, including the European Union and Japan.