Imfinzi’s perioperative approval comes after both the FDA’s staffers and a panel of external experts expressed concerns about overtreatment when using the PD-L1 blocker both before and after surgery.
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The European Union has approved the first-ever combination therapy consisting of an immunotherapy and a PARP inhibitor for the treatment of endometrial cancer, AstraZeneca announced Wednesday.
AstraZeneca beat analyst expectations for its second-quarter revenue on strong demand for its cancer, rare disease and heart disease medicines.
AstraZeneca is proposing to use Imfinzi for resectable non-small cell lung cancer in the perioperative setting—both before and after surgical resection of the tumor. However, ahead of Thursday’s advisory committee meeting, FDA staffers have expressed concerns.
The blockbuster cancer drug Imfinzi has failed as a follow-up therapy to improve disease-free survival in a late-stage trial in patients with a type of early-stage lung cancer.
AstraZeneca on Tuesday announced that its AKT inhibitor Truqap, when used in combination with paclitaxel, failed to meet its primary efficacy endpoint in the Phase III CAPItello-290 study in patients with metastatic triple-negative breast cancer.
The approval came after a late stage trial showed that Imfinzi along with chemotherapy drugs carboplatin and paclitaxel, then followed by Imfinzi by itself, reduced the risk of disease progression or death by 58% in specific endometrial cancer patients, compared to chemotherapy alone.
Following disappointing Phase III results in less aggressive non-small cell lung cancer, AstraZeneca on Friday announced that Imfinzi improved progression-free and overall survival in patients with limited-stage small cell lung cancer.
AstraZeneca on Thursday released its fourth-quarter and full-year financial results, touting 6% total revenue growth for 2023 even as its COVID-19 business plummeted by more than 90%.
When given concurrently with chemoradiotherapy, AstraZeneca’s Imfinzi in a late-stage lung cancer study did not lead to significant improvements in progression-free survival versus chemoradiotherapy alone.