Elritercept Receives FDA Fast Track Designation for MDS Treatment

For patients with lower-risk myelodysplastic syndromes (MDS), the Food and Drug Administration (FDA) granted a Fast Track designation for elritercept (KER-050), a novel treatment for patients with MDS and patients with myelofibrosis, according to a news release from Keros Therapeutics, the manufacturer of the novel drug.

In specific, the drug aims to treat anemia in patients with very low-, low- or intermediate-risk MDS, the release stated.

The American Cancer Society defines MDS as a condition that occurs when “blood-forming cells in the bone marrow become abnormal,” which can lead to a lower number of one or more types of blood cells. This is because the defective cells die quicker than normal cells and when the body destroys some abnormal blood cells, meaning people with MDS may not have enough normal blood cells.

“Receiving Fast Track designation for [elritercept] underscores the need for novel treatment options to address the serious unmet medical needs of people living with lower-risk MDS,” Jasbir S. Seehra, president and chief executive officer of Keros Therapeutics, said in the release. “We look forward to working closely with the FDA as we engage on the design of a phase 3 clinical trial evaluating KER-050 in lower-risk MDS in the first half of this year.”

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The phase 2 clinical trial currently evaluating elritercept in patients with lower-risk MDS includes approximately 140 patients, according to ClinicalTrials.gov.

Patients in the trial receive escalating doses of elritercept subcutaneously (beneath all layers of skin) every four weeks for up to four cycles. After four weeks, patients have the option to either continue for four more weeks at a time or stop treatment. The maximum amount of weeks is 24 weeks to continue receiving four cycles of treatment at a time, according to the listing on ClinicalTrials.gov.

The primary endpoint of the study — main result measured at the end of a study to see if treatment worked, the National Cancer Institute defines — is to evaluate any side effects patients experienced, including what caused them and how serious they were, the listing also reported. Researchers are expected to follow up on side effects from the beginning of the study until the end, which is approximately two years.

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A secondary endpoint of the study included the maximum amount of elritercept patients received, which is measured during multiple points within the two-year period of the study, the listing stated.

Another secondary endpoint, according to ClinicalTrials.gov, aims to evaluate potential disease progression to higher-risk MDS or acute myeloid leukemia (AML), which is similarly measured at multiple points throughout the study.

When MDS progresses beyond higher risk, it may become AML, known to be a rapid-growing cancer within the bone marrow cells, according to the American Cancer Society.

The FDA defines a Fast Track designation as a process that expedites the review of a novel drug that may “treat serious conditions,” and also address unmet needs of respective patient populations that other drugs are currently unable to address. If relevant criteria are met during a Fast Track designation, the drug could be eligible for a priority review or accelerated approval.

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