Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jul 21
- 1 min read
10/07/2026
FDA rejects Elevar’s rivoceranib + camrelizumab HCC NDA due to manufacturing compliance (Ref)
Elevar Therapeutics announced on that the FDA declined to approve its combination therapy of rivoceranib (VEGFR TKI) and camrelizumab (anti–PD-1) as a first-line treatment for unresectable or metastatic hepatocellular carcinoma (HCC)
The rejection stemmed not from efficacy concerns but from manufacturing-related deficiencies found during a cGMP inspection at a facility named in the drug application
CEO Dong-Gun Kim stated the company is reviewing the letter's contents and plans to engage the FDA to clarify next steps, while reaffirming commitment to the HCC patient population
The application was based on the global Phase 3 CARES-310 trial, which showed a median overall survival of 23.8 months for the combination in first-line uHCC patients
Risvutatug Rezetecan delivered first Phase III overall survival benefit vs topotecan, in relapsed small cell lung cancer (Ref)
Hansoh Pharma & GSK's risvutatug rezetecan (HS‑20093), a B7‑H3 directed antibody‑drug conjugate (ADC), met its primary endpoint of overall survival (OS) in a pivotal Phase 3 ARTEMIS‑008 trial for small cell lung cancer (SCLC) patients who had relapsed after platinum‑based therapy
It showed statistically significant and clinically meaningful OS improvement compared with topotecan
Benefits extended to secondary endpoints like progression‑free survival (PFS)
Safety profile consistent with earlier findings; no new safety signals
Upcoming milestones:
Hansoh Pharma will begin regulatory discussions with China’s NMPA to prepare for a Biologics License Application (BLA)
Full data will be presented at an upcoming international oncology conference
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