Regulatory Setbacks continue for Gilead’s magrolimab in AML studies as...

Setbacks continue for Gilead’s magrolimab in AML studies as FDA places partial clinical hold


In a surprising turn of events, Gilead Sciences’ hopes for its magrolimab therapy in the field of acute myeloid leukemia (AML) have been met with another roadblock. Exactly a month after Gilead’s decision to shelve a myelodysplastic syndromes (MDS) program for magrolimab, the promising molecule has now been placed under a partial clinical hold by the U.S. Food and Drug Administration (FDA) for its phase 3 AML studies.

The announcement of this regulatory action was made through a press release by the California-based pharmaceutical company. Despite lacking details about the specific nature of the FDA’s concerns, the release revealed that the hold applies to the enrollment of new patients for magrolimab therapy in AML at U.S.-based locations, as well as for the expanded access program. Although, patients who are already enrolled in the studies will be allowed to continue receiving the treatment and will be closely monitored according to the existing study protocols.

Magrolimab, a monoclonal antibody targeting the CD47 protein, has been under evaluation for its potential in treating various types of cancer, with a focus on its role in limiting tumor growth and proliferation. The goal is to harness the body’s immune system, particularly macrophages, to eliminate cancerous cells more effectively.

However, Gilead’s journey with magrolimab has been anything but smooth. Even before its current setback, the therapy faced a series of clinical holds. Back in 2022, the magrolimab program was temporarily halted for four months due to an observed “apparent imbalance” in adverse reactions among the study participants. These holds spanned multiple trials involving AML, MDS, and myeloid malignancies. Although the FDA eventually lifted the block on the AML and MDS studies in April 2022, other programs, such as those focused on lymphoma and multiple myeloma, remained on hold for several additional months.

Despite these obstacles, Gilead has consistently expressed its confidence in the safety profile and potential benefits of magrolimab. The company’s Chief Medical Officer, Merdad Parsey, M.D., Ph.D., has emphasized their belief in the therapy’s ability to address the unmet medical needs of individuals living with AML and MDS.

“Our confidence in the risk-benefit profile of magrolimab has been unwavering, and we continue to believe in the potential for this treatment to address the unmet medical needs faced by people living with MDS and AML,” Parsey said.

However, Gilead has not provided detailed insights into the reasons behind the various holds that magrolimab has faced throughout its development.

The setback comes at a time when the company had previously announced its decision to discontinue the MDS program for the CD47-targeting therapy. This step followed Gilead’s assessment of phase 3 data, which led to the determination that the MDS program would not yield the anticipated results.

The firm is actively collaborating with regulatory authorities and clinical trial investigators to determine the most suitable course of action to address the concerns raised by the FDA. In the meantime, the company’s solid tumor program remains unaffected, allowing Gilead to maintain focus on this aspect of its research efforts.

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