Global drugs group AstraZeneca plc (NYSES:AZN) added 1.62% in New York after it revealed the all powerful US Food and Drug Administration (FDA) had agreed to speed up the process needed for its new lung cancer drug Imfinzi.
The regulator has granted breakthrough therapy designation, designed to accelerate the review of new medicines for treating serious conditions that have demonstrated encouraging early clinical results.
This is usually awarded when the results show substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.
In May, the FTSE100 pharmaceutical company announced positive interim results from the Phase III Pacific trial of Imfinzi as sequential treatment in patients with stage III non-small cell lung cancer who had not progressed following standard platinum-based chemotherapy concurrent with radiation therapy.
“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,” Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said alongside today’s announcement.
The progress in Imfinzi comes in contrast to a failed Phase II trial of lung cancer treatment, Mystic, last Thursday, which saw billions wiped off Astra's value.
The study did not meet the primary end point of improving progression-free survival compared to chemotherapy.