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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 8 hours ago
- 2 min read
26/06/2026
Henlius’ serplulimab secures EU approval for sqNSCLC (Ref)
The European Commission approved serplulimab (Hetronifly®; anti-PD-1) in combination with chemotherapy for first-line treatment of unresectable locally advanced or metastatic sqNSCLC
The approval was based on the pivotal Phase 3 ASTRUM-004 trial, which demonstrated significant improvements in overall survival (OS) and progression-free survival (PFS) with a manageable safety profile compared to standard of care (Ref)
Median PFS: 8.3 mos vs 5.7 mos; HR: 0.55
Median OS: 22.7 mos vs 18.2 mos; HR 0.73; p=0.010
Gr ≥3 TRAEs: 35.5% vs 57 31.8%
FDA accepts RP1 BLA resubmission for advanced Melanoma; Decision expected by August 2026 (Ref)
The FDA has accepted Replimune’s resubmission of the Biologics License Application (BLA) for RP1 (vusolimogene oderparepvec; oncolytic immunotherapy) in combination with nivolumab for advanced melanoma
It is classified as a complete, class 1 response with a target decision date of August 2, 2026
An FDA advisory committee meeting is scheduled for late July 2026
The resubmission seeks accelerated approval based on data from the IGNYTE trial, which tested RP1 plus nivolumab in patients who had progressed on prior anti-PD-1 therapy
FDA grants tentative approval for enzalutamide tablets, adding new dosing strengths to compete with Xtandi (Ref)
Lupin received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for enzalutamide tablets in 40 mg, 80 mg, 120 mg, and 160 mg strengths
The 40 mg and 80 mg tablets are bioequivalent to Astellas’ reference drug Xtandi®, approved for the same indications
Lupin’s 120 mg and 160 mg strengths provide alternative dosing flexibility for healthcare providers and patients, beyond the traditional 40 mg and 80 mg strengths of Xtandi
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