2025 Novel Oncology Approvals

Exciting year for Oncology! NSCLC definitely reigned in quite a few new products with 6 approvals alone! Interestingly, two of the approved products in the 2nd half are specifically for HER2 positive NSCLC. While a less common mutation of only 2-4% of adenocarcinomas, is one of particularly poor prognosis. Still, there are roughly 35% of NSCLC adenocarcinomas which have unknown or no biomarkers, and still a very high unmet need.

Feb 2026 Update: Originally approved in August 2025, Hernexeos (zongertinib) / Boehringer after at least 1 prior line. Hernexeos is now approved and has become the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option.