FDA Identifies Death Risk, Gilead Halts Cancer Drug

Gilead has halted the progression of its magrolimab program, a drug candidate for blood cancer, following a clinical hold imposed by the FDA. This decision was made after a Phase III study for acute myeloid leukemia (AML) was put on hold, encompassing other studies on the drug, such as those for myelodysplastic syndromes.

The FDA's intervention prompted Gilead to cease further development of magrolimab for blood cancer treatments. An independent committee's review of the drug's combination with venetoclax revealed an elevated risk of mortality due to respiratory failure and infections. Gilead's Chief Medical Officer, Merdad Parsey, acknowledged the intricacies of blood cancer treatment and expressed gratitude to those involved in the Enhance studies.

Patients participating in the Enhance study are now being withdrawn from treatment as Gilead collaborates with researchers to determine the next steps. The company is conducting sub-analyses and intends to share the findings with regulatory bodies. The results may be presented at a future conference or published in a peer-reviewed journal.

Gilead also plans to release all top-line data from the magrolimab trials and will reassess the drug's safety profile across solid tumor trials. The drug had previously faced regulatory hurdles, with a partial clinical hold in August 2023 and the discontinuation of its use in myelodysplastic syndromes in September 2023 due to underwhelming outcomes.

Magrolimab was acquired by Gilead as part of a $4.9 billion acquisition of Forty Seven in 2020. The announcement of the drug's development suspension coincided with Gilead's reported 4% revenue decline in the fourth quarter of 2023, particularly impacted by reduced sales in its COVID-19 and HIV product lines.