Gilead combo therapy hit with FDA hold over serious adverse events
pharmafile | January 27, 2022 | News story | Business Services |
The FDA has placed a partial clinical hold on studies conducted by Gilead Sciences assessing the combination of magrolimab plus azacitidine, due to concerns of unexpected serious adverse events between study arms.
Gilead Sciences reported an “apparent imbalance” in investigator-reported suspected unexpected serious adverse reactions (SUSARs). The company said there has been no clear trend in the reporting of adverse reactions. Despite this, Gilead said that the partial hold has been placed on all ongoing magrolimab and azacitidine combination studies worldwide, to protect patients whilst additional data is being analysed.
Magrolimab is a potential, first-in-class investigational monoclonal antibody against CD47 and a macrophage checkpoint inhibitor. It is designed to interfere with the recognition of CD47 by the SIRPa receptor on macrophages, to block the “don’t eat me” signal used by cancer cells. Gilead Sciences gained magrolimab in its 2020 $4.9 billion acquisition of Forty Seven Inc.
Gilead assesses the combination in multiple trials, including three Phase III studies in myelodysplastic syndrome (MDS) and two in acute myeloid leukaemia.
“Considering the high unmet need for new medicines in myelodysplastic syndrome and acute myeloid leukaemia, we will work closely with regulatory authorities worldwide to continue the magrolimab development program appropriately,” Parsey said in a statement.
“We remain confident in the potential of magrolimab across a broad range of tumors, including the other, ongoing magrolimab studies. We are grateful to those participating in our studies, their families, and the investigators for their continued contributions to the clinical program for magrolimab.”
Lina Adams
