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Biological products

FDA Grants Fast Track Designation to Heidelberg Pharma's Pamlectabart Tismanitin for Multiple Myeloma Treatment

Strategic Insights

— 2 min read

The FDA has granted fast track designation to HDP-101, an investigational antibody drug conjugate (ADC), as a therapy for patients with multiple myeloma. This decision was based on supporting data from nonclinical findings and clinical data from an ongoing phase 1/2a study (NCT04879043). The study, led by Dr. Shambavi Richard, is evaluating the antitumor activity and safety of HDP-101 among patients with relapsed/refractory multiple myeloma. Notably, prior findings from this trial were shared at the 2025 European Hematology Association Congress (EHA), highlighting promising results for the novel BCMA-targeting ADC.

Key Takeaways:

  • The FDA has granted fast track designation to HDP-101, an investigational antibody drug conjugate (ADC) for the treatment of patients with multiple myeloma.
  • The decision was based on supporting data from nonclinical findings and clinical data from an ongoing phase 1/2a study (NCT04879043).
  • Investigators are currently evaluating the antitumor activity and safety of HDP-101 among patients with relapsed/refractory multiple myeloma.
  • Prior findings from the trial were shared at the 2025 European Hematology Association Congress (EHA), highlighting promising results for the novel BCMA-targeting ADC.
  • The study has enrolled 34 patients across 7 consecutive dose cohorts, with a median patient age of 69 years and a median number of prior treatment lines of 5.
  • The trial's primary end points are dose-limiting toxicities in part 1 of the study and objective response rate.
  • Secondary end points include safety and tolerability, and clinical efficacy based on progression-free survival and overall survival.
  • Patients with known central nervous system involvement, plasma cell leukemia, or a history of congestive heart failure are ineligible for study entry.
  • The FDA's granting of fast track designation is seen as a significant milestone for Heidelberg Pharma and underscores the potential of HDP-101 for the treatment of severely ill and heavily pretreated patients.

Statistics:

  • 34 patients have been enrolled in the ongoing phase 1/2a study (NCT04879043).
  • The median patient age is 69 years (range, 43-82).
  • The median number of prior treatment lines is 5 (range, 2-15).
  • 7 consecutive dose cohorts have been completed, with no patients experiencing grade 4 thrombocytopenia or dose-limiting toxicities.
  • The study's primary end points are dose-limiting toxicities in part 1 of the study and objective response rate.

Sources:

  • PR: Heidelberg Pharma's lead ADC candidate HDP-101 granted fast track designation by US FDA for the treatment of multiple myeloma. News release. Heidelberg Pharma AG. October 23, 2025. Accessed October 23, 2025.
  • Richard S, Orlowski RZ, Kaufman J, et al. The anti-BCMA antibody-drug conjugate HDP-101 with a novel amanitin payload shows promising data in relapsed/refractory multiple myeloma in a phase 1/2a clinical trial as it advances into cohort 7. Presented at the 2025 European Hematology Association Congress (EHA); June 12-15, 2025; Milan, Italy. Abstract PF749.
  • Study to assess safety of HDP-101 in patients with relapsed refractory multiple myeloma. ClinicalTrials.gov. Updated July 24, 2024. Accessed October 23, 2025.

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