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AZ’s Imfinzi seals blockbuster lung cancer market with FDA nod

Published on 19/02/18 at 08:57am

AstraZeneca’s immunotherapy, Imfinzi, arrived to the industry as a failure – there were big hopes resting on the company’s Mystic trial, with the potential to leapfrog other treatments on the market with a successfully combination treatment.

Of course, in one of the biggest stories of last year, it did not succeed and instead wiped $10 billion from the company’s value.

However, AZ remained confident the drug could be a driver of growth and this, at least partially, may come true after the FDA gave approval for the drug’s use in unresectable Stage III non-small cell lung cancer (NSCLC), for use with patients whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

How much could this approval be worth to the company? Some analysts have it pegged as a $2 billion per year area, helped by the failure of other immunotherapies to successfully enter the space previously.

The approval for use in lung cancer came on the back of data showing an improvement in progression-free survival of 16.8 months when patients were treated with Imfinzi, compared with placebo treatment of 5.6 months.

Dave Fredrickson, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, 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.”

Only 15% of patients in this setting survive the five-year mark, meaning that Imfinzi’s approval is a much needed treatment in the area.

This could explain why the FDA’s decision comes a month earlier than had been expected, alongside its more concerted push to speed through approvals across all areas since Scott Gottlieb was appointed commissioner.

While, for AZ, there is still the full readout from the Mystic trial’s overall survival data to see if the Imfinzi and tremelimumab combo still has legs, with the results expected to be revealed later this year.

Ben Hargreaves

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