{"id":59120,"date":"2018-02-17T12:03:25","date_gmt":"2018-02-17T12:03:25","guid":{"rendered":"https:\/\/www.biphoo.com\/bipnews\/?p=59120"},"modified":"2018-02-17T12:03:25","modified_gmt":"2018-02-17T12:03:25","slug":"astrazenecas-immunotherapy-drug-wins-key-lung-cancer-approval","status":"publish","type":"post","link":"https:\/\/www.biphoo.com\/bipnews\/health\/astrazenecas-immunotherapy-drug-wins-key-lung-cancer-approval.html","title":{"rendered":"AstraZeneca’s immunotherapy drug wins key lung cancer approval"},"content":{"rendered":"

AstraZeneca’s immunotherapy drug wins key lung cancer approval<\/span><\/strong><\/span><\/h2>\n

AstraZeneca\u2019s immunotherapy drug Imfinzi has won crucial approval from U.S. regulators for use in lung cancer, opening up a multibillion-dollar market for a medicine that has so far lagged behind competitors.<\/span><\/p>\n

The U.S. Food and Drug Administration said late on Friday it granted approval for expanded use of Imfinzi to treat non-small cell lung cancer (NSCLC) patients with inoperable mid-stage disease that has not spread widely around the body.<\/span><\/p>\n

Imfinzi is the first immunotherapy to be approved in this setting.<\/span><\/p>\n

The green light – which had been expected following positive clinical data last year – gives AstraZeneca a chance to intervene earlier in lung cancer, distinguishing it from rivals that have approval for tackling advanced or metastatic disease.<\/span><\/p>\n

Analysts believe using Imfinzi in so-called stage III lung cancer, where cancer has only spread locally, opens up an annual sales opportunity worth around $2 billion. Importantly, AstraZeneca has a lead of two to three years over other drug companies in this particular area.<\/span><\/p>\n

The approval was based on a trial involving 713 patients, showing patients survived on average 16.8 months without their disease worsening when given Imfinzi, against just 5.6 months for those on placebo.<\/span><\/p>\n

Globally, approximately 30 percent of patients with NSCLC present with stage III disease. These individuals typically receive a combination of chemotherapy and radiotherapy, but only around 15 percent of them are still alive after five years.<\/span><\/p>\n

Imfinzi, chemically known as durvalumab, belongs to a new class of immuno-oncology drugs that block a mechanism tumours use to evade detection from the immune system.<\/span><\/p>\n

AstraZeneca\u2019s drug already had approval for treating certain patients with bladder cancer. However, this market is relatively small.<\/span><\/p>\n

The really big opportunity for all companies seeking to exploit the power of modern immuno-oncology drugs is lung cancer, since it is the leading cause of cancer deaths.<\/span><\/p>\n

Bristol-Myers Squibb, Roche and Merck all have approved products for treating certain patients with advanced lung cancer – but AstraZeneca is now in a position to carve out a niche in treating earlier stage III patients.<\/span><\/p>\n

AstraZeneca still hopes to catch up in the advanced lung cancer market, too, by combining Imfinzi with another immunotherapy drug called tremelimumab.<\/span><\/p>\n

Initial results from a clinical trial testing this combination proved disappointing last July but the company has a second chance to prove the case for its cocktail when overall survival data are released later this year.<\/span><\/p>\n

Some analysts forecast potential sales of all immunotherapy drugs at as much as $50 billion a year. Still, significant challenges remain, including deciding on optimal treatment regimens for using infused medicines with typical list prices near $150,000 a year.<\/span><\/p>\n

Source:-\u00a0https:\/\/www.reuters.com\/article\/us-astrazeneca-fda\/astrazenecas-immunotherapy-drug-wins-key-lung-cancer-approval-idUSKCN1G02IA<\/span><\/p>\n

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