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AstraZeneca scores much-needed clinical success

04:18 EDT 2 Aug 2017 | Proactive Investors

AstraZeneca PLC (LON:AZN) has scored some much needed clinical success following that may go some way to compensating for the failure of a much-hyped combination therapy for lung cancer. It has been granted a priority review by the US Food & Drug Administration (FDA) for acalabrutinib, which has been developed to treat a rare form of non-Hodgkin’s lymphoma. The new drug application is based on data from a phase II clinical trial on patients with relapsed and or refractory mantle cell lymphoma. It is incredibly rare to see a treatment jump from phase II to the regulatory sign-off stage in this way. Traditionally, a treatment must undergo a rigorous phase III test first. Priority review... Priority review status, meanwhile, is only granted to applications for medicines that, if approved, would offer a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions. AZ’s acalabrutinib has also received breakthrough therapy designation from the FDA. The treatment is a highly-selective, potent, Bruton tyrosine kinase (BTK) inhibitor. BTK’s offer a breakthrough in treating blood-borne cancers. The success follows almost a week on from the abject failure of AZ’s MYSTIC study, which assessed the potential to use two of the company’s drugs to treat lung cancer. The bad news wiped around 15% off the share price.

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