On Friday, the FDA accepted and granted Priority Review AstraZeneca Plc's (NASDAQ:AZN) supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) for patients with muscle-invasive bladder cancer (MIBC).
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the second quarter of 2025.
The supplement application is based on data from the NIAGARA Phase 3 trial.
Also Read: FDA Approves AstraZeneca's Blockbuster Cancer Drug Imfinzi For Aggressive Form Of Lung Cancer
In the trial, patients were treated with Imfinzi in combination with neoadjuvant chemotherapy before radical cystectomy, followed by Imfinzi as adjuvant monotherapy or neoadjuvant chemotherapy before radical cystectomy.
In a planned interim analysis, perioperative Imfinzi demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone.
The estimated median event-free survival (EFS) for the Imfinzi arm has not yet been reached, versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the Imfinzi regimen were event-free at two years, compared to 59.8% in the comparator arm.
Results from the key secondary endpoint of overall survival (OS) showed that the Imfinzi perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy.
Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the Imfinzi regimen were alive at two years, compared to 75.2% in the comparator arm.
On Thursday, a pooled analysis of the TROPION-Lung05 phase 2 and the TROPION-Lung01 phase 3 trials showed datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
These data and progression-free and overall survival results from the analysis were presented at the 2024 ESMO Asia Congress.
Daiichi Sankyo (OTC:DSKYF) (OTC:DSNKY) and AstraZeneca's datopotamab deruxtecan showed a 42.7% objective response rate in previously treated patients.
Five (4.3%) complete responses, 45 (38.5%) partial responses, and 48 (41.0%) cases of stable disease were observed.
The median duration of response was 7.0 months, and the disease control rate was 86.3%. Median progression-free survival was 5.8 months, and median overall survival was 15.6 months.
Price Action: At last check on Friday, AZN stock was up 1.45% to $68.51 during the premarket session.
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