AstraZeneca down 15% premarket on failed late-stage study on lung cancer candidate durvalumab; Merck up 5% on improved prospects for Keytruda (July 27)
Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the marketing application.
Shares plummeted after the company announced failed results from the Phase 3 MYSTIC study.
Shares have rebounded over 8% since bottoming at $28.43 last Thursday.
The FDA designates AstraZeneca’s (AZN +6.5% ) IMFINZI (durvalumab) a Breakthrough Therapy for the treatment of locally advanced, unresectable non-small lung cancer (NSCLC) that has not progressed after platinum-based chemo, the second such designation for the PD-L1 inhibitor (it received accelerated approval in May in the U.S. for urothelial carcinoma).
Durvalumab Granted Breakthrough Therapy Designation by Food and Drug Administration for NSCLC
ORR was 16.4% (95% CI, 10.8-23.5) in patients with PD-L1 expression ≥25%, and 7.5% (95% CI, 3.1-14.5) in patients with PD-L1 expression levels of
Durvalumab Granted Breakthrough Therapy Designation by FDA for NSCLCJason HarrisSean Bohen, MD, Phd Sean Bohen, MD, PhdDurvalumab (Imfinzi) has been granted a breakthrough therapy designation by the FDA to treat patients with locally-advanced, unresectable non-small cell lung cancer (NSCLC) whose disease has not progressed following platinum-based chemoradiation.AstraZeneca and its global biologics research and development arm MedImmune, announced the FDA action in a press release.
The highest overall response rate (ORR) of 30.9% (95% CI, 20.2-43.3) occurred in patients with PD-L1 expression on ≥90% of tumor cells.
The designation, which will expedite the development and review of durvalumab in this setting, is based on interim results from the phase III PACIFIC trial, in which the PD-L1 inhibitor significantly improved progression-free survival (PFS) compared with placebo.
Patients were randomized in a 2:1 ratio to durvalumab or placebo.
AstraZeneca: Food and Drug Administration Grants Breakthrough Therapy Designation For Imfinzi
The Breakthrough Therapy Designation for Imfinzi was granted on the basis of interim results from the Phase III PACIFIC trial.
(RTTNews) – AstraZeneca plc (AZN.L, AZN) and MedImmune, its global biologics research and development arm, said that the U.S. Food and Drug Administration or FDA has granted Breakthrough Therapy Designation for Imfinzi (durvalumab) for the treatment of patients with locally-advanced, unresectable non-small cell lung cancer or NSCLC whose disease has not progressed following platinum-based chemoradiation therapy.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said, “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.”
The trial is 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 Breakthrough Therapy Designation is designed to expedite the development and regulatory review of new medicines that are intended to treat a serious condition and have shown encouraging early clinical results by demonstrating substantial improvement on a clinically-significant endpoint over available medicines and when there is significant unmet medical need.
This content may collect you by Victoria Hunter