Onco-Summaries: Daily Oncology Updates at a Glance

18/09/2025

Replimune completed a Type A meeting with the FDA to discuss the CRL for vusolimogene oderparepvec + nivo (Ref)

Replimune announced the completion of a Type A meeting with the US FDA discussing the CRL for the BLA of vusolimogene oderparepvec (RP1; herpes simplex virus engineered and genetically armed with a fusogenic protein (GALV-GP R-) and GM-CSF) + nivo for the treatment of anti-PD-1 pretreated advanced melanoma.

• The feedback from the FDA provided during the meeting is being evaluated to determine next steps

  
  

• To note, a path forward under the accelerated approval pathway has not been determined

Minovia Therapeutics' MNV-201 received the FDA Fast Track Designation for MDS (Ref)

The US FDA granted the Fast Track Designation to Minovia Therapeutics' MNV-201 (cell therapy utilizing Mitochondrial Augmentation Technology) for Myelodysplastic Syndrome (MDS).

• Natalie Yivgi-Ohana, Co-founder and CEO, Minovia: “The Fast Track Designation in MDS is further validation of the urgency and potential for our science, which targets the mitochondria, a critical multi-functional organelle. FDA designations such as the FTD help us to decrease the potential time to market and provide additional benefits across the FDA process that, we expect, will prove both medically and financially valuable.”