FDA Expands AstraZeneca's (AZN) Imfinzi Label in Lung Cancer
AstraZeneca AZN announced that the FDA expanded the label of its blockbuster cancer drug Imfinzi for a fourth indication in lung cancer.
The FDA approved Imfinzi in combination with platinum-based chemotherapy for treating adults with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) with no known EGFR mutations or ALK rearrangements. While the Imfinzi-chemotherapy combo will be administered before surgery, Imfinzi monotherapy will be given after surgery.
This approval is based on data from the phase III AEGEAN study, which showed that treatment with an Imfinzi-based regimen reduced the risk of recurrence, progression or death by 32% in resectable early-stage NSCLC patients compared with chemotherapy alone.
Imfinzi is already approved for a similar indication in the U.K., Switzerland and Taiwan based on data from the AEGEAN study. A regulatory filing is currently under review in the European Union and China.
Imfinzi is already approved in the U.S. for three lung cancer indications — two in NSCLC (across different settings) and one in extensive-stage small cell lung cancer (ES-SCLC). Apart from lung cancer, the drug is also approved in the country for biliary tract cancer, endometrial cancer and hepatocellular carcinoma (HCC) indications.
AstraZeneca’s shares have risen 26.0% year to date compared with the industry’s 24.8% growth.
Imfinzi is a key revenue driver for AZN’s oncology portfolio, having generated sales worth $2.26 billion in the first half of 2024, up 25% year over year at constant exchange rates. The demand for the drug is being driven by increased use in recent launches like biliary tract and HCC cancers and rising patient demand across lung cancer indications.
