FDA Gives Breakthrough Therapy Designation to Relapsed/Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm Drug


IMGN632 granted breakthrough designation for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm.

The FDA has granted a breakthrough therapy designation to IMGN632 for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN), according to an announcement from ImmunoGen, Inc, the drug developer.1 The designation was based on data from the BPDCN cohort of the first-in-human phase 1/2b trial (NCT03386513) of the CD123-targeted antibody-drug conjugate (ADC). Results presented during the 2019 ASH Annual Meeting showed that IMGN632 showcased preliminary activity in this patient population, along with those who had relapsed/refractory acute myelogenous leukemia (AML).2

Specifically, results showed that 2 of 9 patients with BPDCN achieved a complete response with or without complete hematologic recovery (CR/CRi) and 1 patient experienced a partial response. Moreover, 13 of 71 patients with AML achieved a CR/CRi with the ADC. Notably, responses were reported across the patient subsets represented in the overall study population, and in the majority of cases, they occurred following the first or second dose of IMGN632. Updated data from the trial will be presented at the 2020 ASH Annual Meeting, according to ImmunoGen.

“We are pleased [the] FDA has granted breakthrough therapy designation for IMGN632, our novel CD123-targeted ADC, as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive. Cancer,” Mark Enyedy, president and chief executive officer of ImmunoGen, stated in a press release. “We look forward to continuing to work with [the] FDA to further define the development path for IMGN632 in AML and other hematological malignancies.”

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