AstraZeneca’s Imfinzi gets Breakthrough Therapy Designation from FDA
31 Jul 2017
AstraZeneca today said its global biologics research and development arm MedImmune has been granted 'breakthrough therapy designation' for 'Imfinzi' (durvalumab) by the US Food and Drug Administration.
Imfinzi is meant for to treat patients with ''locally-advanced, unresectable non-small cell lung cancer'' (NSCLC), whose disease had not progressed following platinum-based chemoradiation therapy.
According to the FTSE 100 company, the designation was designed to expedite the development and regulatory review of new medicines that were intended to treat a serious condition, and that had shown ''encouraging'' early clinical results which demonstrated ''substantial improvement'' on a clinically-significant endpoint over available medicines and when there was significant unmet medical need.
''For patients who have not progressed following chemoradiation therapy the only current option is active monitoring,'' said AstraZeneca chief medical officer and executive vice president of global medicines development Sean Bohen.
''Unfortunately, for the majority of patients, their cancer will progress to metastatic disease, typically within 12 months.''
According to the board, the 'breakthrough therapy designation' for Imfinzi comes after interim results from the Phase III PACIFIC trial - a randomised, double-blinded, placebo-controlled multi-centre trial of Imfinzi as sequential treatment in patients with locally-advanced, unresectable (Stage III) NSCLC who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy.
The US Food and Drug Administration has agreed to speed up the process required for development and regulatory review of AstraZeneca PLC's new lung cancer drug Imfinzi (durvalumab).
"Imfinzi is the first immuno-oncology medicine to show a clinically-significant benefit in this earlier, non-metastatic setting, so following the Breakthrough Designation we hope to bring it to patients as soon as possible," addded Bohen.