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AstraZeneca has received its first US FDA approval for a new cancer treatment that the company hopes will be a “cornerstone” of its new immuno-oncology portfolio as it looks to return to growth.
The FDA granted accelerated approval to the company’s Durvalumab drug – under the brand name Imfinzi – for use with previously treated patients with advanced bladder cancer.
The announcement is the first approval for Durvalumab, which is also being developed for use on other tumour types including lung cancer and head and neck cancer.
A key test of whether it will be able to fulfill hopes of reaching blockbuster status – with sales of at least $1bn – will come after a key trial for its use in lung cancer treatment, the results of which are expected around the middle of the year.
Immuno-oncology treatments seek to use the body’s own immune system to attack cancer cells.
Astra has been betting on new product development to help bring an end to five years of sales declines and offset the impact of patent expiries on its older drugs. Last week it said 2017 would be a “pivotal year” for the company’s future as it awaits the results of trials.
Pascal Soriot, AstraZeneca chief executive, said:
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.