In February 2018, durvalumab (IMFINZI®) was approved in the US for the treatment of patients with unresectable, stage III non-small cell lung cancer (NSCLC), whose cancer has not progressed after chemoradiation therapy.[1]This is the second indication for durvalumab, developed by AstraZeneca via Medimmune; the agent was approved in 2017 in the US (May)[2] and Canada (November)[3] for use in patients with bladder cancer.

NSCLC is estimated to account for up to 85% of all lung cancer diagnoses. The American Cancer Society has estimated that about 234,030 new cases of lung cancer will be diagnosed in 2018, of those about 66% will be fatal.[4]

The probability of survival is dependent on the stage of disease at first diagnosis: the predicted 5-year survival rate for patients with stage I ranges from 92-68% (depending on associated complications), whereas that for patients with stage III disease drops to about 36-13%.[4] Unfortunately, about 30% of patients, globally, present with Stage III disease.[5]

“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,” explained Scott J. Antonia, M.D., Ph.D., Chair of the Thoracic Oncology Department at the H. Lee Moffitt Cancer Center and Research Institute in Tampa, Florida and investigator in the PACIFIC trial.[5]

This latest approval for durvalumab, granted via Priority Review and breakthrough designations, was based on the positive results from the phase III PACIFIC trial.[6]

A detailed review about the first global approval of durvalumab in the US, is available in Adis’ journal Drugs[7], and is based on the development milestones of the agent tracked in AdisInsight.[8]

 

 

Image credit: Image credit: Tim Gouw on Unsplash

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