Onco-Summaries: Daily Oncology Updates at a Glance

11/11/2025

Allterum Therapeutics' 4A10 received the FDA fast track designation for ALL (Ref)

The US FDA granted the fast track designation to Allterum Therapeutics' 4A10 (anti-IL-7Rα) for the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL).

• Yan Moore, CEO, Allterum Therapeutics: "The FDA's Fast Track designation for 4A10 affirms its potential and empowers us to work hand-in-hand with the agency to bring this therapy to patients and families as quickly as possible." 

March Biosciences' MB-105 CAR-T received the RMAT designation for CD5-positive T-cell lymphoma (Ref)

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 relapsed/refractory CD5-positive T-cell lymphoma.

• The RMAT designation was granted based on results from the Phase 2 NCT06534060 trial

• Sarah Hein, Co-Founder and CEO, March Biosciences: “The FDA’s RMAT designation further validates MB-105’s potential to address a critical unmet medical need for patients with relapsed/refractory T-cell lymphoma, who face a median survival of only six months with current therapies. We are encouraged by the responses observed to date and look forward to working closely with the FDA to advance MB-105 as efficiently as possible.”