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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Dec 11
- 1 min read
10/12/2025
GSK's risvutatug rezetecan received the FDA orphan drug designation for SCLC (Ref)
The US FDA granted the orphan drug designation to GSK's risvutatug rezetecan (B7-H3-targeted ADC) for the treatment of small-cell lung cancer (SCLC).
The ODD was based on preliminary clinical data of the Phase 1 ARTEMIS-001 trial in which the ADC showed durable responses in patients with extensive stage SCLC
Ajax Therapeutics' AJ1-11095 received the FDA orphan drug designation for myelofibrosis (Ref)
The US FDA granted the orphan drug designation to Ajax Therapeutics' AJ1-11095 (JAK2 inhibitor) for the treatment of myelofibrosis.
AJ1-11095 is currently being evaluated in the Phase 1 NCT06343805 trial in patients with myelofibrosis who have been previously treated with a Type I JAK2 inhibitor and have either not responded or have lost response
David Steensma, CMO, Ajax: “Orphan Drug Designation is an important milestone in our clinical development of AJ1-11095 for the treatment of myelofibrosis. This designation reinforces the compelling need for effective new treatment options for patients suffering from myelofibrosis, and supports our continued efforts to advance AJ1-11095 to address the unmet need for patients who would benefit from improved treatment efficacy, or who have not responded to existing therapies."
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