Heidelberg Pharma’s lead ADC Candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma

CAR-T Digest - August 2020

23 October 2025: Heidelberg Pharma’s lead ADC Candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma

The US FDA granted fast track designation to Heidelberg Pharma’s lead ADC HDP-101 (Pamlectabart tismanitin) for relapsed or refractory multiple myeloma, underscoring its potential to address a high unmet medical need
The designation positions HDP-101 as a strategically differentiated amanitin-based ADC platform, enhancing Heidelberg Pharma’s profile in next-generation oncology therapeutics
This regulatory milestone allows closer FDA interaction, rolling BLA review, and potential eligibility for Priority Review or Accelerated Approval, accelerating time-to-market
The decision was supported by nonclinical and early clinical data from the ongoing Phase 1/2a trial showing safety and antitumor activity in heavily pretreated myeloma patients
The fast-track status reinforces Heidelberg Pharma’s strategy to advance its proprietary ADC pipeline efficiently toward commercialization in hard-to-treat hematologic malignancies