Myeloma

Myeloma treatment HDP-101 put on FDA fast track

The U.S. Food and Drug Administration (FDA) has granted fast track designation to HDP-101 (pamlectabart tismanitin), a multiple myeloma therapy currently in early clinical testing.

The FDA gives this designation to promising investigational therapies that, based on early data, have the potential to address unmet medical needs in the management of serious diseases. The designation aims to speed the development of new medicines that are urgently needed. As part of the designation, the therapy’s developer Heidelberg Pharma will get access to perks like more frequent communication with the FDA during the drug development process.

“The FDA’s granting of Fast Track Designation is fantastic news for Heidelberg Pharma and underscores the potential of HDP-101 for the treatment of severely ill and heavily pretreated patients,” Andreas Pahl, PhD, CEO of Heidelberg, said in a company press release.

The designation was supported by preclinical experiments as well as data from an ongoing Phase 1/2 clinical trial (NCT04879043) testing the safety of HDP-101 in adults with myeloma whose disease has come back or failed to respond to prior treatment. Pahl said the designation “will support our efforts to advance [HDP-101] efficiently toward patients with multiple myeloma who continue to face significant unmet medical needs.”

Myeloma is a type of blood cancer marked by the uncontrolled growth of plasma cells, which are immune cells that produce antibodies. The cancer grows in bone marrow  — the spongy tissue inside bones where new blood cells are made. Myeloma treatments are available, but they aren’t always successful at eradicating the disease.