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Oncology Updates - Key Oncology News
- Oncofocus Team
- 1 day ago
- 2 min read
April 4th Week, 2026
Regulatory Events
🎯 The EC granted conditional marketing authorization to Ipsen’s tovorafenib (Ojemda; type II RAF kinase inhibitor) monotherapy for the treatment of pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies (Ref 1)
❓ What is the addressable market for pLGG in EU?
🎯 The US FDA accepted a supplemental BLA for Pfizer and Astellas Pharma’s enfortumab vedotin–ejfv (PADCEV; Nectin-4 ADC) + Merck & Co./MSD’s pembrolizumab (Keytruda or Keytruda QLEX; anti-PD-1) as perioperative treatment for MIBC, regardless of cisplatin eligibility (Ref 2)
❓ How will this change Pfizer/Astellas and Merck’s market share in the MIBC Tx landscape?
Special Designations
⭐ The US FDA granted the Fast Track Designation to Debiopharm’s lunresertib (PKMYT1 inhibitor) + zedoresertib (WEE1 inhibitor) for platinum-resistant/refractory ovarian cancer with specific genomic alterations (CCNE1 amplification, FBXW7 or PPP2R1A mutations) (Ref 3)
❓ Which are the other key assets in the development landscape of ovarian cancer?
⭐ The US FDA granted the Orphan Drug Designation to Orion Pharma’s ODM-212 (pan- Transcriptional Enhanced Associate Domain inhibitor) for mesothelioma (Ref 4)
❓ What is the current SOC for treating mesothelioma in the US?
Setbacks
🛑 Merck & Co./MSD and Eisai US’ Phase 3 LITESPARK-012 trial did not meet the dual primary endpoints of PFS and OS for first-line treatment of advanced clear cell RCC. Both experimental regimens - pembrolizumab (KEYTRUDA; anti-PD-1) + lenvatinib (LENVIMA; multiple receptor TKI) + belzutifan (WELIREG; HIF-2α inhibitor) and MK-1308A (pembrolizumab + quavonlimab [anti-CTLA-4] co-formulation) + lenvatinib failed to outperform pembrolizumab + lenvatinib (Ref 5)
❓ What were the efficacy outcomes that established KEYTRUDA + LENVIMA as the SOC?
🛑 Arcus Biosciences and Gilead Sciences discontinued the Phase 3 STAR-121 trial of domvanalimab (anti-TIGIT) + zimberelimab (anti-PD-1) + chemotherapy vs pembrolizumab + chemotherapy in previously untreated metastatic NSCLC patients, and a related Phase 2 trial, due to futility (Ref 6)
❓ Which are the active TIGIT assets in the NSCLC development landscape?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
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