FDA grants breakthrough status to IMGN632 for blastic plasmacytoid dendritic cell neoplasm
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The FDA granted breakthrough therapy designation to IMGN632 for treatment of relapsed or refractory blastic plasmacytoid dendritic cell neoplasm, according to the agent’s manufacturer.
IMGN632 (ImmunoGen) — an antibody-drug conjugate that targets CD123 — is in development for treatment of hematologic malignancies, including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia and acute lymphocytic leukemia.
BPDCN — a rare but aggressive blood cancer — has features of both lymphoma and leukemia. Patients typically develop skin lesions and lymph node involvement, and the disease often spreads to the bone marrow.
Patients typically undergo intense treatment, followed by stem cell transplantation.
The FDA approved a CD123-targeting therapy; however, there remains an unmet need for effective treatments, particularly for patients with relapsed or refractory disease.
The agency granted breakthrough designation to IMGN632 based on data presented at last year’s ASH Annual Meeting and Exposition.
“We are pleased FDA has granted breakthrough therapy designation for IMGN632 ... as it underscores the urgent need for effective and well-tolerated treatments for patients with this rare and aggressive cancer,” Mark Enyedy, president and CEO of ImmunoGen, said in a company-issued press release. “We look forward to continuing to work with FDA to further define the development path for IMGN632 in BPDCN, in addition to pursuing our ongoing evaluation of IMGN632 in AML and other hematological malignancies.”
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