Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Aug 4
- 2 min read
31/07/2026
FDA grants tentative approval for OMCAZIO, a lower-dose Cabozantinib formulation with improved absorption (Ref)
Handa Oncology announced that the US FDA has granted tentative approval for OMCAZIO (cabozantinib; multikinase inhibitor) capsules, a novel alternate-salt formulation of cabozantinib developed under the 505(b)(2) pathway
OMCAZIO is approved for advanced RCC (alone or with nivolumab), previously treated HCC, and unresectable/metastatic extra-pancreatic neuroendocrine tumors (epNET) in adults and pediatric patients ≥12 years
Bioequivalent to CABOMETYX® at lower doses, with improved absorption and no clinically significant food effect
Handa is preparing for full FDA approval and market launch
Annamycin shows 37% CRc in Venetoclax-failed AML patients, with unblinded arms reaching up to 57% (Ref)
Moleculin reported positive interim data from its ongoing Phase 2/3 MIRACLE trial in relapsed/refractory acute myeloid leukemia (R/R AML). The update highlights efficacy signals in patients who previously failed venetoclax (BCL‑2 inhibitor) therapy, a population with historically poor outcomes
Blinded interim results (n=62):
Complete remission (CR): 24%
Composite complete remission (CRc): 37%
Venetoclax-failure subgroup (n=30):
CR: 23%
CRc: 37%, ~3x higher than published salvage remission rates (~13%)
CRc has remained stable (~37–40%) across successive blinded analyses (30, 45, 62 patients)
No evidence of cardiotoxicity, differentiating Annamycin from conventional anthracyclines
Interim Unblinded Data (June 2026, n=45)
Annamycin arms showed clear efficacy advantage:
CRc: 50% and 57% vs 29% for control
Enrollment reaches 74 of 90 patients, with final Part A treatment expected in September 2026 and comprehensive unblinded Part A results on track for the planned December 2026-February 2027 timeframe
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