FDA will seek input from the Oncologic Drugs Advisory Committee on Wednesday 2 September re: review of Allos Therapeutics’ (NASDAQ: ALTH) New Drug Application for pralatrexate (Folotyn); for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma. It appears as though reviewers have questioned some findings reported by the Company on the effectiveness of its proposed drug.
FDA issues with the Allos application appear to be:
- The clinical significance of tumor response and duration of response, and
- Whether the benefit:risk ratio is favorable
Take a look at the FDA Briefing Document [HERE].