FDA Oncology Approvals: December 2025 Roundup

The FDA continues to advance precision oncology with new approvals. Here are the highlights from recent months.

Targeted Therapies

KRAS G12C Inhibitors Expand

Following the success of sotorasib and adagrasib in NSCLC, the KRAS G12C inhibitor class continues to grow:

• New indications in pancreatic and colorectal cancers under review
• Combination trials showing promising results
• Next-generation inhibitors entering Phase 2/3 trials

RET Inhibitor Updates

Selpercatinib and pralsetinib continue to show durable responses in RET-altered cancers, with new pediatric approvals expanding access.

Immunotherapy Advances

Expanded Biomarker-Based Approvals

The FDA's tissue-agnostic approach continues with approvals based on molecular features rather than tumor location:

• MSI-H/dMMR: Multiple checkpoint inhibitors now approved
• TMB-High: Pembrolizumab approved for solid tumors with TMB ≥10 mut/Mb
• NTRK Fusions: Larotrectinib and entrectinib remain options across tumor types

What This Means for Patients

These approvals highlight the importance of comprehensive genomic profiling. Knowing your tumor's molecular profile can open doors to targeted treatments that weren't available just a few years ago.

Stay Updated

Use ClinicalMatch.ai to find trials testing the next generation of targeted therapies for your specific mutations.