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AstraZeneca's Imfinzi Gets US FDA Nod for Bladder Cancer Combo Therapy

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AstraZeneca's Imfinzi Gets US FDA Nod for Bladder Cancer Combo Therapy

The US Food and Drug Administration approved AstraZeneca's (AZN.L, AZN,ST) Imfinzi, or durvalumab, in combination with another drug for the treatment of non-muscle-invasive blood cancer, or NMIBC, the British drugmaker said Thursday.

The approval is based on positive results from the Potomac phase 3 trial, which showed a 32% reduction in the risk of high-risk recurrence, progression, or death after one year of Imfinzi in combination with Bacillus Calmette-Guerin, or BCG, induction and maintenance therapy, compared with BCG alone.

The durvalumab-BCG combo is the first therapy to be approved in the US in over 30 years for BCG-naive, high-risk NMIBC. Authorities in the European Union, Japan and other countries are also reviewing regulatory submissions based on the phase 3 trial results, AstraZeneca said.

Over 31,000 people were treated for high-risk NMIBC in the US in 2024, according to the drugmaker. Half of patients with the condition are at high risk of experiencing disease recurrence or progression, with up to 80% of high-risk patients seeing recurrence within five years of treatment.

"Unfortunately, many of these patients experience disease recurrence requiring repeated surgical procedures, as well as disease progression resulting in surgical removal of their bladder," said Neal Shore, director of START Carolinas and a co-principal investigator in the phase 3 trial. "The POTOMAC trial demonstrates that the durvalumab with BCG induction and maintenance regimen reduces the risk of disease recurrence, progression or death for patients by almost a third compared to BCG alone, heralding a marked advancement for patients with high-risk non-muscle-invasive bladder cancer."

Imfinzi is also approved in several countries for patients with cisplatin-eligible muscle-invasive bladder cancer.

The drug generated $1.69 billion in revenue for AstraZeneca in the first quarter, up 30% year over year at constant exchange rates, making it the second-highest earning product in the company's oncology portfolio, behind Tagrisso.

Shares of the drugmaker rose 1% in early trading in London on Friday.

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