FDA approves AstraZeneca’s bladder cancer drug

WASHINGTON — AstraZeneca and its global biologics research and development arm, MedImmune, announced the Food and Drug Administration has granted accelerated approval to Imfinzi (durvalumab), which is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. 

Imfinzi is approved under the FDA’s accelerated approval pathway, based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

“We are excited to offer Imfinzi as a breakthrough therapy for patients with locally-advanced or metastatic bladder cancer,” said Pascal Soriot, CEO of AstraZeneca. Imfinzi is the cornerstone of our extensive immuno-oncology program, in development across many tumor 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 recommended dose of Imfinzi is 10 mg/kg body weight administered as an intravenous infusion over 60 minutes every two weeks until disease progression or unacceptable toxicity.

The accelerated FDA approval of Imfinzi, a human monoclonal antibody that blocks PD-L1, is based on data from Study 1108. This Phase I/II trial evaluated the safety and efficacy of Imfinzi in patients with locally-advanced or metastatic urothelial carcinoma of the bladder. Patients had progressed while on or after a platinum-containing chemotherapy, including those who progressed within 12 months of receiving therapy in a neoadjuvant or adjuvant setting.