Case Study: Karyopharm Therapeutics achieves expedited FDA approval for myeloma patients with TransPerfect

TransPerfect enables Karyopharm to speed up FDA drug approval for myeloma patients

Karyopharm Therapeutics faced a high-stakes regulatory challenge: they needed an inspection-ready Trial Master File (TMF) and more than 60,000 words of critical documentation translated for an NDA submission over a single weekend. They engaged TransPerfect, leveraging its Trial Interactive technology along with TMF management and translation services to meet these urgent requirements.

TransPerfect deployed its Trial Interactive platform and translation teams to prepare the TMF and translate 60,000+ words in record time, enabling Karyopharm Therapeutics to submit the NDA on schedule and ultimately secure FDA approval for their first product, XPOVIO. The rapid turn-around directly supported the timely filing and approval, accelerating access for myeloma patients.

Karyopharm Therapeutics