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FDA lifts partial clinical hold on Curis cancer drug in lymphoma study

 

Most cancers drug developer Curis now has the FDA’s blessing to renew one in every of two scientific trials that had been paused within the spring following a affected person dying. Curis stated Thursday that the FDA lifted the partial scientific maintain on an early-stage lymphoma research after the corporate got here up with a plan to deal with a doubtlessly deadly complication.

The standing stays unchanged up to now for a separate partial maintain on a research testing the identical Curis drug, emavusertib, in leukemia. The reported dying occurred on this Section 1/2a research, main the FDA to pause the trial on April 4. At the moment, Lexington, Massachusetts-based Curis additionally voluntarily paused a Section 1/2 research testing the drug in lymphoma as a precaution. The next week, the FDA positioned a partial maintain on that trial as effectively. Each partial holds permitted sufferers at the moment enrolled to proceed to obtain the experimental drug, however barred the enrollment of any new sufferers.

Curis stated in April that the affected person who died skilled a dose-limiting aspect impact known as rhabdomyolysis. This complication is characterised by the dying of muscle tissue, which releases muscle fibers and different substances into the blood that injury organs, akin to the center and kidneys. Rhabdomyolysis is a recognized complication of the Curis drug, which is a small molecule designed to dam IRAK4, a protein that’s a part of a pathway that’s usually dysregulated in sufferers with most cancers.

In its announcement of the carry of the partial maintain on the lymphoma research, Curis didn’t disclose any extra particulars in regards to the affected person dying within the leukemia research. However the biotech stated that after reviewing a complete information bundle submitted by the corporate, the FDA has agreed to Curis’s technique for figuring out and managing rhabdomyolysis within the lymphoma research, which is designed to check a 300 mg dose of emavusertib twice day by day. Curis stated that as a part of its settlement with the FDA, the corporate can even enroll at the very least 9 extra sufferers on the 200 mg dose degree.

Curis is working with scientific trial websites to renew enrollment of recent lymphoma sufferers within the third quarter, CEO James Dentzer stated in a ready assertion. The corporate now expects to have scientific information from this research in 2023.

Photograph: ClarkandCompany, Getty Photos

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