Oncology Updates - Key Oncology News
- Oncofocus Team
- Aug 13
- 1 min read
August 1st Week, 2026
Regulatory Events
🎯 The US FDA granted an accelerated approval to Replimune's vusolimogene oderparepvec-wtpg (TUDRIQEVTM/RP1; oncolytic viral therapy) + Bristol Myers Squibb and Ono Pharma's nivolumab (Opdivo; anti-PD-1) for the Tx of adults with unresectable advanced cutaneous melanoma with disease progression on prior anti-PD-1 based regimen (Ref)
❓ How is this approval expected to impact the ≥2L Melanoma Tx paradigm?
🎯 Dr. Reddy's Laboratories rituximab biosimilar (anti-CD20; reference product: Rituxan®) was approved by the US FDA; Fresenius Kabi holds exclusive commercialization rights for the product in the US market (Ref)
❓ What is the expected impact of this approval on Rituxan's market share?
Special Designations
⭐ The US FDA granted a Breakthrough Therapy Designation to Eli Lilly and Company's olomorasib (KRAS G12C inhibitor) as monotherapy for KRAS G12C-mutant advanced pancreatic cancer in adults who have received at least one prior systemic therapy (Ref)
❓ How is olomorasib positioned in the KRAS mutant pancreatic cancer landscape?
⭐ Zai Lab's zocilurtatug pelitecan (Zoci; DLL3 ADC) has been granted the Orphan Drug Designation by the US FDA for the Tx of neuroendocrine carcinomas (NECs) (Ref)
❓ What is the current SOC for NEC in the US?
⭐ BioInvent International AB's BI-1808 (anti-TNFR2) + Merck&Co./MSD's pembrolizumab (Keytruda; anti-PD-1) has been granted a Fast Track Designation by the US FDA for the Tx of ovarian cancer (Ref)
❓ How do the POC outcomes of BI-1808 compare with the SOC in ovarian cancer?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
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