FDA Agrees To Review Ozekibart For Metastatic Chondrosarcoma

The Food and Drug Administration (FDA) has agreed to review a new drug called Ozekibart to treat a rare and aggressive type of bone cancer called chondrosarcoma. This cancer develops in the cartilage cells of bones, and it is especially dangerous because there are currently no approved full-body medical treatments for it when it spreads or cannot be removed by surgery. The FDA has set a target date of April 14, 2027, to make its final decision on whether to approve the drug, which would make it the first official therapy of its kind for these patients.

The drug’s application is backed by a global clinical study involving 206 patients. In the trial, Ozekibart successfully doubled the amount of time patients lived without their cancer getting worse—extending it to about 5.5 months compared to roughly 2.6 months for those taking a placebo. The drug works by triggering a specific target on cancer cells that forces them to self-destruct. While it did cause some side effects like fatigue, nausea, and potentially dangerous liver irritation in early stages, researchers have since successfully managed these risks by excluding patients with severe pre-existing liver issues and closely monitoring everyone during their first few weeks of treatment.

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