AstraZeneca (NASDAQ: AZN, LON: AZN) , the UK-based pharmaceutical powerhouse, has secured US FDA approval for a new indication of its PD-L1 inhibitor, Imfinzi (durvalumab). The FDA has authorized the use of Imfinzi in combination with chemotherapy for adults with resectable early-stage non-small cell lung cancer (NSCLC) classified as IIA-IIIB, specifically for patients without EGFR or ALK mutations.
The treatment protocol involves administering Imfinzi alongside chemotherapy prior to surgery (neoadjuvant setting), followed by Imfinzi as a monotherapy post-surgery (adjuvant therapy).
This approval is based on the pivotal AEGEAN clinical trial, which demonstrated a 32% reduction in the risk of cancer recurrence, progression, or death when compared to neoadjuvant chemotherapy alone (CI 0.53-0.88; p=0.003902). The trial also revealed a significant improvement in pathologic complete response (pCR), with a rate of 17.2% for the combination therapy versus 4.3% for chemotherapy alone.
Imfinzi is already approved in the UK, Switzerland, and Taiwan for the early-stage NSCLC indication highlighted in the AEGEAN trial. Initially approved in 2017 for bladder cancer, Imfinzi has garnered eight indication approvals from the US FDA to date. The drug has proven to be a commercial success, generating over USD 1 billion in quarterly sales, with Q2 2024 sales reported at USD 1.147 billion, reflecting an 18% year-on-year growth.
Additionally, Imfinzi recently received both priority review and breakthrough therapy designation for its potential use in treating limited-stage small-cell lung cancer (LS-SCLC), with a PDUFA date set for Q4 2024.- Flcube.com
