SAR’579/IPH6101 Granted FDA Fast Track Designation for Hematological Malignancies

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SAR'579 / IPH6101 Granted FDA Fast Track Designation for Hematological Malignancies

Source: Innate Pharma

On June 6, 2023, the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to SAR’579/IPH6101 for the treatment of hematological malignancies. Fast Track Designation is a special status provided by the FDA to expedite the development and review of medications targeting serious conditions and addressing unmet medical needs. This designation aims to accelerate the availability of important new drugs for patients, covering a wide range of severe illnesses.

SAR’579, which is the leading asset of the ANKET® platform, is a trifunctional anti-CD123 NKp46×CD16 NK cell engager. It originated from a collaborative research effort between Innate Pharma and Sanofi, and it is currently being developed by partner Sanofi. This designation recognizes the potential of SAR’579/IPH6101 to address the urgent medical needs of patients with hematological malignancies.

“It is promising to see SAR’579 / IPH6101 was granted Fast Track Designation in the US for the treatment of hematological malignancies, and congratulate our partner Sanofi on this milestone,” said Mondher Mahjoubi, Chief Executive Officer of Innate Pharma. “In addition to the encouraging clinical data recently presented at the 2023 ASCO Annual Meeting, this FDA Fast Track Designation further validates the potential of the ANKET® platform to treat cancer patients with NK Cell Engagers.”

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