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Pharma & Biotech

AstraZeneca receives double EU recommendation for cancer drug

Lynparza is recommended for marketing authorisation for ovarian and prostate cancer, while Tagrisso showed positive results in late-stage trials for lung cancer

AstraZeneca PLC (LON:AZN) revealed it has received a double recommendation in the European Union for its cancer drug Lynparza.

The FTSE 100-listed group[ said the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the candidate for marketing authorisation for both HRD-positive advanced ovarian cancer and in advanced prostate cancer with a BRCA mutation.

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In the case of ovarian cancer, the drug was advised as a first-line maintenance treatment with bevacizumab after late-stage trials showed the combination reduced the risk of disease progression or death by 67%.

Ovarian cancer is the fifth most common cause of cancer death in Europe and the five-year survival rate is 45%, in part because women are often diagnosed with advanced disease.

Prostate cancer is the second-most common type of cancer in men, with an estimated 1.3mln new patients diagnosed worldwide in 2018, while 12% of patients have a BRCA mutation.

Lynparza is currently approved in several countries for certain types of ovarian, breast and pancreatic tumours.

In a separate announcement, the pharma giant said that another cancer treatment, Tagrisso has shown a clinically meaningful improvement in patients with early-stage non-small-cell lung cancer (NSCLC) after the tumour had been removed completely.

In the phase III trials, 11% of patients treated with Tagrisso had recurrence events or deaths compared to 46% on placebo.

Tagrisso is currently approved as a first-line treatment for other types of NSCLC in several countries but nowhere as an adjuvant, which is aimed at stopping the tumour coming back after the primary treatment.