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Oncology Updates - Key Oncology News
- Oncofocus Team
- Nov 19
- 2 min read
November 2nd Week, 2025
🎯 The US FDA granted full approval to Kura Oncology, Inc. and Kyowa Kirin Co., Ltd.'s ziftomenib (menin inhibitor) for adult patients with R/R AML with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. (Ref 1)
❓ How is this approval expected to impact the Tx algorithm of AML?
🔬 In the Phase 3 PEAK trial, Cogent Biosciences' bezuclastinib (KIT inhibitor) + sunitinib met the primary endpoint of PFS in patients with imatinib-resistant or intolerant Gastrointestinal Stromal Tumors. (Ref 2)
❓ What are the current SOC benchmarks for this indication?
⭐ The US FDA awarded a Commissioner’s National Priority Voucher (CNPV) to Boehringer Ingelheim's zongertinib (HER2 TKI) for the treatment of patients with HER2-mutant NSCLC. (Ref 3)
❓ Which other assets have received the FDA CNPV in oncology?
⭐ The US FDA granted the Regenerative Medicine Advanced Therapy (RMAT) designation to March Biosciences' MB-105 (autologous CD5-targeted CAR-T cell therapy) in development for R/R CD5-positive T-cell lymphoma. (Ref 4)
❓ What percentage of T-cell lymphoma patients are CD5 positive?
⭐ The US FDA granted the fast track designation to Avenzo Therapeutics and Duality Biologics' AVZO-1418/DB-1418 (EGFR x HER3 bispecific ADC) for the treatment of patients with unresectable, locally advanced, or metastatic NSCLC with an EGFR exon 19 deletion or exon 21 L858R mutation, whose disease has progressed on or after therapy with an EGFR TKI. (Ref 5)
❓ What are the other key ADCs being developed for this indication?
⭐ The US FDA granted the fast track designation to Allterum Therapeutics' 4A10 (anti-IL-7Rα) for the treatment of patients with R/R Acute Lymphoblastic Leukemia. (Ref 6)
❓ What were the clinical outcomes that supported the designation?
⭐ The US FDA granted the orphan drug designation to Purdue Pharma L.P.'s tinostamustine (HDAC inhibitor) for the treatment of malignant gliomas. (Ref 7)
❓ What are the key unmet needs of this indication?
To know answers to these questions and for additional insights, write to us at support@oncofocus.com.
🌐 References:
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