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Gilead Sciences pauses enrollment globally in magrolimab solid tumor studies
Foster City: Gilead Sciences, Inc. has announced that it has paused enrollment globally in the magrolimab solid tumor studies. The U.S. Food and Drug Administration (FDA) subsequently requested a partial clinical hold on these trials. This request is in addition to the previously announced full clinical hold on all magrolimab studies in acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS) requested by the FDA.
"Gilead is reviewing the benefit-risk of magrolimab across all ongoing trials and will provide an update on this assessment as soon as possible.
Patients already enrolled in the Gilead-sponsored ELEVATE solid tumor studies and deriving clinical benefit may continue to choose receiving magrolimab following reconsenting to the study with their healthcare provider," the Company stated in a recent release.
The Gilead-sponsored ELEVATE solid tumor studies impacted by the partial clinical hold include:
- Phase 2 study in head and neck squamous cell carcinoma (NCT04854499)
- Phase 2 study in solid tumors (NCT04827576)
- Phase 2 study in triple-negative breast cancer (NCT04958785)
- Phase 2 study in colorectal cancer (NCT05330429)
The enrollment hold also applies to Investigator Sponsored Studies with magrolimab in solid tumors.
Read also: Gilead Sciences to acquire CymaBay Therapeutics for USD 4.3 billion
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751