Foghorn Therapeutics pauses enrolment in cancer drug study
Foghorn Therapeutics pauses enrolment in cancer drug study
(Reuters) - Drug developer Foghorn Therapeutics Inc. said on Monday it has paused enrolment in an early-stage study of the company's experimental drug for a rare form of cancer due to safety concerns.
The company said the U.S. Food and Drug Administration has also placed the study on partial hold in the United States, while allowing patients currently enroled and benefiting from therapy to continue dosage of the drug, FHD-609.
One of the patients', who was receiving the second highest dosage of the drug in the study, heart muscle was taking longer than normal to contract between beats.
Foghorn said it was not planning to pursue a dose expansion study independently.
The drug developer said it has also informed European health regulators on the adverse event related to the clinical trial.
FHD-609 was undergoing early-stage study to treat patients with a rare form of cancer in soft tissue called synovial sarcoma and as a potential treatment for tumours arising from the absence of the SMARCB1 gene.