Potential blockbuster AZ immunotherapy secures FDA approval

The FDA has granted accelerated approval to AstraZeneca’s (AZ) immunotherapy therapy Imfinzi (durvalumab) for the treatment of locally advanced or metastatic urothelial carcinoma – better known as bladder cancer – in patients  who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

The approval means AZ can now take the fight to rivals BMS and Roche who are already taking advantage of the small market. Imfinzi presents sizeable benefits to previously untreated patients, for whom the drug is currently undergoing trials, due to release results later in the year. AZ has high hopes for the drug, expecting sales to eventually make it into the billions.

By the terms of the accelerated approval, AZ is required to continue an ongoing clinical trial in order to generate enough data to validate the drug’s efficacy. The company revealed that the average cost of wholesale acquisition will be approximately $15,000 per month.

AstraZeneca Chief Executive Pascal Soriot called the decision "an important milestone in our return to growth", while a statement from the firm read: "Imfinzi is approved under the FDA's accelerated approval pathway, based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials."