The US Food and Drugs Administration has approved AstraZeneca’s drug Imfinzi (durvalumab) for the treatment of Stage III non-small cell lung cancer.

The drug has been approved for patients whose cancer has not progressed following concurrent platinum-based chemotherapy and radiation therapy, and is unresectable─ cannot be removed completely through surgery. It is the only immunotherapy approved for this indication, putting AstraZeneca ahead of competitors in this area.

The company’s shares rose 1% in early trade following the announcement. The approval opens up an annual sales opportunity worth an estimated $2 billion.

The approval was based on the positive progression-free survival data from the Phase III PACIFIC trial. In the trial, which involved 713 participants, Imfinzi showed an 11.2 month improvement in median progression-free survival─16.8 months compared to 5.6 months on placebo.

Investigator in the PACIFIC trial Dr Scott Antonia said: “Until now, treatment guidelines have recommended that patients with unresectable Stage III lung cancer undergo a period of active surveillance following chemoradiation therapy until disease progression. Given that up to 89% of patients will progress to metastatic disease, it is important that there is now a new option that can give patients more time without disease progression. The PACIFIC trial data supporting today’s approval of Imfinzi will change how we treat these patients.”

Imfinzi received accelerated approval in the US for the treatment of patients with locally-advanced or metastatic urothelial cancer in May 2017.

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By GlobalData

In July 2017, AstraZeneca’s share prices plummeted after a trial showed that Imfinzi failed to improve progression-free survival in stage four lung cancer patients. Several setbacks in the company’s drug pipeline in 2017 caused share prices to drop by as much as 15%.

Lung cancer is the second most common type of cancer and the leading cause of cancer death, with an estimated 155,870 lung cancer deaths in the US in 2017. About 80% to 85% of lung cancers are non-small cell lung cancer.

Durvalumaba is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics.

Executive vice president and head of the Oncology Business Unit at AstraZeneca Dave Fredrickson said: “The approval of Imfinzi in this earlier stage of non-small cell lung cancer is a truly meaningful milestone for patients who, until now, had no FDA-approved treatment options following chemoradiation therapy. Globally, approximately 30% of patients with NSCLC present with Stage III disease and we are excited to launch the first immunotherapy into this setting.”