AstraZeneca’s Imfinzi receives FDA-accelerated approval for urothelial cancer

The US Food and Drug Administration (FDA) has granted accelerated approval to AstraZeneca’s Imfinzi (durvalumab) for the treatment of urothelial cancer.

Imfinzi (durvalumab), previously known as MEDI4736, is a human monoclonal antibody that blocks the interaction of PD-L1 with PD-1 and CD80.

PD-L1 is widely expressed in tumour and immune cells of urothelial carcinoma patients that prevent the tumours from detection through binding to the PD-1 receptor on cytotoxic T lymphocytes.

Imfinzi is indicated to treat patients affected with locally advanced or metastatic urothelial carcinoma (MUC) exhibiting disease progression during or following platinum-containing chemotherapy.

It can also be treated with those who have shown disease progression within 12 months from receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

AstraZeneca CEO Pascal Soriot said: "We are excited to offer Imfinzi as a breakthrough therapy for patients with locally advanced or metastatic bladder cancer.

"Imfinzi is the cornerstone of our extensive immuno-oncology programme in development across many tumour types as monotherapy and in combination.

"This first approval for Imfinzi is an important milestone in our return to growth and brings us another step closer to our goal of redefining the way cancer is treated."

The accelerated approval was based on data from Study 1108, in which Imfinzi demonstrated rapid and durable responses.

"This first approval for Imfinzi is an important milestone in our return to growth and brings us another step closer to our goal of redefining the way cancer is treated."

This Phase I/II trial assessed the safety and efficacy of Imfinzi in patients with locally advanced or metastatic urothelial carcinoma of the bladder and have progressed with platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting.

Imfinzi is recommended in 10mg/kg of body weight dosage and administered as an intravenous infusion over 60 minutes every fortnight until disease progression or unacceptable toxicity.

Urothelial carcinoma is the ninth most common form of cancer worldwide.

Last year, an estimated 430,000 people were diagnosed with bladder cancer globally, 165,000 of which did not survive.