The FDA accepted a supplemental biologics license application (sBLA) and granted a priority review to Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC), according to AstraZeneca, the drug’s manufacturer.
The FDA has accepted a supplemental biologics license application (sBLA) and granted a priority review to Imfinzi (durvalumab) for the treatment of patients with previously untreated extensive-stage small cell lung cancer (SCLC), according to AstraZeneca, the drug’s manufacturer.
Am sBLA occurs when a drug manufacturer officially asks the FDA to introduce/deliver a therapy across state commerce, while a priority review speeds up the FDA’s review of a drug or therapy, potentially leading to an approval quicker than anticipated.
The sBLA was based on positive results from the phase 3 CASPIAN trial, designed to evaluate Imfinzi with or without tremelimumab plus chemotherapy, of which both arms were compared with platinum/etoposide chemotherapy alone. The interim analysis — which were recently published in The Lancet and presented at the IASLC 20th World Conference on Lung Cancer — included 268 patients randomized to the Imfinzi /chemotherapy regimen and another 269 who were treated with chemotherapy alone.
Results from the study showed that Imfinzi plus standard-of-care chemotherapy demonstrated an improvement in overall survival (OS) rates, defined by the start of treatment until the time of patient death. The risk for death was reduced by 27%, with average OS of 13 months for the combination versus 10.3 months for chemotherapy alone.
Results also showed an estimated 33.9% of patients were alive at 18 months following treatment with the combination compared with 24.7% of patients receiving standard of care.
The CASPIAN trial, which is being conducted in over 200 location across 23 countries, is continuing until the final OS analysis for the cohort of patients receiving Imfinzi plus tremelimumab and chemotherapy.
A Prescription Drug User Fee Act date, which is when the FDA must make a decision to approve or not approve the drug indication, is set for the first quarter of 2020.