Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 3 days ago
- 1 min read
27/08/2026
US FDA granted Fast track designation for Varseta-M in R/R Colorectal Cancer (Ref)
CytomX Therapeutics announced that the US FDA has granted Fast Track designation to Varsetatug masetecan (Varseta-M; EpCAM targeting ADC) for patients with relapsed/refractory metastatic colorectal cancer (R/R mCRC), based on encouraging Phase 1 data.
A registrational monotherapy trial in R/R mCRC is planned for 1H 2027
FDA clears path for Phase III melanoma trial of ruxotemitide + pembrolizumab (Ref)
Lytix Biopharma received positive US FDA feedback on its proposed Phase III trial of ruxotemitide (LTX-315; oncolytic peptide) + pembrolizumab vs pembrolizumab alone in high-risk resectable melanoma, with event-free survival (EFS) as the primary endpoint
The FDA indicated that a single well-controlled study may support a New Drug Application if overall data are compelling
Interim results from the ongoing Phase II NeoLIPA study showed strong efficacy among the first 9 evaluable patients
Overall pathological response: 88%
Major pathological response: 55%
Complete pathological response: 44%
Top-line results are expected in H2 2026
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