The FDA has accepted AstraZeneca’s sBLA for Imfinzi based on positive results from the phased III CASPIAN trial
Image: AstraZeneca building in Gaithersburg, USA. Photo: Courtesy of AstraZeneca.
AstraZeneca has secured priority review status from the US Food and Drug Administration (FDA) for its Imfinzi (durvalumab) to treat of patients with previously untreated extensive-stage small cell lung cancer (SCLC).
The regular has accepted the company’s supplemental biologics licence application (sBLA) based on positive results from the phased III CASPIAN study.
The trial showed that Imfinzi in combination with standard-of-care (SoC) chemotherapy (etoposide with either cisplatin or carboplatin) demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) against SoC
CASPIAN is a randomised, open-label, multi-centre, global and phase III study in the first-line treatment of patients with extensive-stage SCLC. It compared Imfinzi in combination with etoposide and either cisplatin or carboplatin chemotherapy, or Imfinzi, tremelimumab and chemotherapy vs. chemotherapy alone.
Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80
The patients have been treated with up to four cycles of chemotherapy in the experimental arms. In comparison, the control arm enabled up to six cycles of chemotherapy and prophylactic cranial irradiation.
AstraZeneca will continue the trial to the final analysis of OS for the combination of Imfinzi, tremelimumab and chemotherapy.
With OS as the primary endpoint, the study is being carried out in over 200 centres across 23 countries, including the US, Europe, South America, Asia and the Middle East.
Imfinzi (durvalumab) is a human monoclonal antibody, which binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80. It also secured approval for previously treated patients with advanced bladder cancer in 11 countries, including the US.
Imfinzi is being assessed as a monotherapy and in combination with tremelimumab to treat patients with NSCLC, as part of a broad development programme.
Based on the Phase III PACIFIC trial, the imfinzi is approved in the curative-intent setting of unresectable, stage III NSCLC after chemoradiation therapy in 54 countries.
Earlier this month, the FDA accepted AstraZeneca and MSD’s NDA and granted priority review for selumetinib as a potential new medicine for neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) in paediatric patients.
As part of a global licence agreement, AstraZeneca and MSD are jointly developing and commercialising Lynparza (selumetinib).