Onco-Summaries: Daily Oncology Updates at a Glance
Updated: Sep 1
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
NMPA conditional approval granted for Asandeutertinib in NSCLC with CNS metastases (Ref)
TYK Medicines announced that Asandeutertinib Mesylate Tablets (TY-9591; EGFR-TKI) have received conditional marketing approval from China’s National Medical Products Administration (NMPA) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with CNS metastases harboring EGFR exon 19 deletion (19DEL) or exon 21 (L858R) mutations
Multiple studies are ongoing in monotherapy and combination regimens across advanced NSCLC sub-indications
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