Australian stem-cell company Mesoblast (ASX:MSB) will meet with the US FDA on the regulator's review of the company's remestemcel-L in paediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
The meeting will take place with the FDA's Oncologic Drugs Advisory Committee (ODAC).
The ODAC has reviewed the company's phase three data on remestemcel-L and will vote at the meeting on whether it supports its use in paediatric patients with SR-aGVHD.
The ODAC is an independent panel of experts that provides advice and appropriate recommendations to the FDA based on potential issues highlighted by the FDA during their review of the efficacy and safety of marketed and investigational products for use in the treatment of cancer.
Earlier this week, Mesoblast issued pre-meeting briefing materials that triggered a negative response from investors, with the company's share price down by around 30 per cent.
The briefing materials suggest the ODAC believes more evidence might be required to support the approval of remestemcel-L.
According to the briefing, "FDA’s position is that the product attributes the Applicant has identified as related to potency and activity do not have a demonstrated relationship to the clinical performance of specific [drug protocol] lots, and that the product’s proposed immunomodulatory mechanism of action has not been demonstrated in vivo in study subjects receiving remestemcel-L."