FDA Grants Priority Review to Boehringer's Zongertinib for HER2-Mutant Advanced Lung Cancer
• Boehringer Ingelheim's zongertinib could become the first oral targeted therapy for previously treated HER2-mutant advanced non-small cell lung cancer, with FDA decision expected in Q3 2025.
• Phase Ib trial demonstrated impressive 71% objective response rate in 75 previously treated NSCLC patients, with favorable safety profile and low treatment discontinuation rate.
• The drug addresses a significant unmet need in HER2-mutant NSCLC patients, who currently face poor prognosis with limited treatment options and less than 30% five-year survival rate.
Radiopharmaceuticals Reshape Cancer Treatment Landscape: From Thyroid to Advanced Prostate Cancer
• Radiopharmaceuticals have evolved from pioneering thyroid cancer treatments to cutting-edge therapies like Lutathera for neuroendocrine tumors and Pluvicto for PSMA-positive prostate cancer.
• Supply chain challenges and short half-lives of radiopharmaceuticals necessitate careful coordination between radiopharmacists, oncologists, and nuclear medicine specialists for timely delivery and administration.
• Emerging developments include Actinium-225 for treatment-resistant cancers and new targeted therapies for lung, breast, and colorectal cancers, with approximately 60-70 startups conducting clinical trials.
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