Onco-Summaries: Daily Oncology Updates at a Glance
23/09/2026
US FDA approves LYRFIGTU™ (lirafugratinib) in FGFR2-Altered Cholangiocarcinoma (Ref)
Elevar Therapeutics announced US FDA approval of LYRFIGTU™ (lirafugratinib), an irreversible and selective FGFR2 inhibitor, for the treatment of previously treated unresectable, locally advanced, or metastatic cholangiocarcinoma harboring an FGFR2 fusion or other rearrangement
Approval is supported by results from the Phase 1/2 ReFocus trial
Efficacy endpoint | Phase 1/2 ReFocus trial results |
Confirmed objective response rate (ORR) | 46% |
Median duration of response (mDOR) | 11.8 months |
Median progression-free survival (PFS) | 11.3 months |
The company plans to make LYRFIGTU commercially available in the US by Q4 2026
SOTIO Advances SOT106 with Additional FDA Designations in Sarcoma (Ref)
SOTIO announced that the investigational SOT106 (LRRC15-targeting ADC) received Fast Track Designation for osteosarcoma and Orphan Drug Designation for soft tissue sarcoma (STS) from US FDA, supporting its planned clinical development
The company highlighted encouraging preclinical data demonstrating anti-tumor activity, favorable tolerability, and a high therapeutic index in sarcoma models
A first-in-human clinical trial is expected to initiate later in 2026
In Phase 3 MajesTEC-3 study, TECVAYLI + DARZALEX FASPRO demonstrates durable survival outcomes and substantial progression risk reduction in RRMM (Ref)
Johnson & Johnson reported new model-based analyses from the Phase 3 MajesTEC-3 study evaluating TECVAYLI® (teclistamab) in combination with DARZALEX FASPRO® (daratumumab) in patients with relapsed/refractory multiple myeloma (RRMM) after 1-3 prior lines of therapy
The analyses further support the regimen's potential to substantially improve long-term survival outcomes and disease control compared with standard-of-care regimens
Metric | TECVAYLI + DARZALEX FASPRO | Key Finding vs SoC |
Projected Remaining Life Expectancy | 18.5 years | ~3.8x longer vs 4.9 years |
Patients Approaching General Population Mortality Risk | ~87% | Potential for near-normal life expectancy |
3-Year Overall Survival | 83.3% | +18.3 percentage points vs 65.0% |
Disease Progression at 36 Months | 8.7% | vs 62.1% with SoC |
Progression Risk Reduction | 90% | Significant PFS benefit |
Mortality Risk Reduction* | 78% | After first 10 months |
Non-Relapse Mortality | Comparable to SoC | No meaningful increase observed |
*After first 10 months
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