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# Heidelberg Pharma’s Myeloma Drug Gets Fast Track
- URL: https://www.fdaweb.com/heidelberg-pharmas-myeloma-drug-gets-fast-track/
- Published: 2025-10-23T12:00:00.000Z
- Updated: 2026-09-14T15:24:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160092

FDA has granted Heidelberg Pharma a fast track designation for HDP-101 (pamlectabart tismanitin), the company’s lead amanitin-based antibody drug conjugates candidate. The designation was based on data from the ongoing Phase 1-2a study that is evaluating the drug’s safety and antitumor activity in patients with relapsed or refractory multiple myeloma.

HDP-101 is said to be engineered to precisely deliver a potent payload to cancer cells while minimizing harm to healthy cells. The pamlectabart component is a monoclonal antibody that targets the B-cell maturation antigen, a protein overexpressed on the surface of multiple myeloma cells. The tismanitin component is a cytotoxic derivative of alpha-amanitin, a potent poison derived from a mushroom.