AstraZeneca share price: Pharmco wins FDA breakthrough status for cancer drug

on Feb 17, 2016
Updated: Oct 21, 2019

AstraZeneca’s (LON:AZN) shares have been in demand today after the pharmco announced that it had won fast-track US regulatory approval for a particular application of its most promising cancer drugs.

Durvalumab, an immunotherapy drug that uses the body’s own defence system to attack tumours, has been given breakthrough therapy designation (BTD) by the US Food and Drug Administration (FDA) for inoperable or metastatic urothelial bladder cancer. By being given the BTD the FDA will take a more “all hands-on-deck” approach and give AstraZeneca ongoing guidance and feedback throughout the clinical development process, which should speed through the drug’s regulatory process.

Durvalumab was granted this designation based on early clinical data from a phase I trial in patients with advanced metastatic urothelial bladder cancer whose tumour has progressed during or after one standard platinum-based regimen. The compound is also being tested in first-line bladder cancer on its own, as well as in combination with tremelimumab.
“Metastatic bladder cancer is an area of enormous unmet medical need,” said Robert Iannone, AstraZeneca’s global head of immuno-oncology. “We are encouraged by this Breakthrough Therapy designation. We look forward to working closely with the FDA to bring durvalumab to bladder cancer patients as soon as possible,” he added.
Investors have reacted positively to the news, sending AstraZeneca’s share price 1.89 percent higher to 4,263.00p as pf 14:50 GMT. The FTS 100 benchmark had meanwhile gained 2.03 percent to stand at 5,981.04 points.
As of 15:02 GMT, Wednesday, 17 February, AstraZeneca plc share price is 4,265.50p.