FDA Will Expedite Review of Omblastys to Treat Metastatic, Pediatric Neuroblastoma

If approved, Omblastys will be the first FDA-approved drug for children with neuroblastoma that has spread to the central nervous system or leptomeninges.

The Food and Drug Administration (FDA) granted Omblastys (omburtamab) a priority review for a Biologics License Application for the treatment of children with central nervous system or leptomeningeal metastasis (disease that spread to the cerebrospinal fluid that surrounds the brain and spin cord) from neuroblastoma.

In doing so, the agency agreed to speed up the review of the agent, which could ultimately lead to it being OK’d to enter the U.S. marketplace. The FDA plans on making an approval decision for Omblastys by Nov. 30, 2022.

“We believe that the FDA’s acceptance of our Omblastys (Biologics License Application) for priority review is a significant achievement for Y-mAbs and a crucial step forward as we anticipate that Omblastys, if approved by the FDA, can address a significant unmet medical need for children with (central nervous system)/leptomeningeal metastasis from high-risk neuroblastoma, where no standard therapy currently exists,” Thomas Gad, founder, president and interim CEO of Y-mAbs, the manufacturer of Omblastys said in a press release.

Current treatment options for high-risk neuroblastoma include chemotherapy, surgery, stem cell rescue, radiation and monoclonal antibody therapy. There is currently no cure for the disease, and recent research has revealed outcome disparities in patients with neuroblastoma being treated on a clinical trial.

According to Y-mAbs, Omblastys is a radioactive drug that works by targeting cells that express B7-H3, which inhibits the actions of T cells, thereby allowing for cancer cells to grow and proliferate.

The priority review is based on findings from two ongoing clinical trials that are showing that the drug may be safe and effective for this patient population.

“We look forward to working with the agency to bring Omblastys to the appropriate patients,” Gad said.

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