FDA grants orphan drug designation to novel glioblastoma treatment
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The FDA granted orphan drug designation to rhenium nanoliposomes for the treatment of patients with recurrent glioblastoma, according to a manufacturer-issued press release.
Rhenium nanoliposomes (Plus Therapeutics) is designed to safely deliver a dose of radiation directly into the brain tumor that is 25 times greater than what is delivered using external beam radiation therapy. The treatment is under investigation in the NIH/NCI-supported, multicenter ReSPECT phase 1 clinical trial.
Based on approval from the trial’s data safety and monitoring board, the trial will proceed to testing a higher drug volume of 8.8 mL and radiation dose of 22.3 mCi.
“Receiving FDA orphan drug designation and approval to advance the trial into cohort 6 are key milestones in our development of this treatment for recurrent glioblastoma,” Marc Hedrick, MD, president and CEO of Plus Therapeutics, said in the release. “We believe [rhenium nanoliposomes] has the potential to prolong survival for patients with malignant brain tumors and that of other difficult-to-treat radiosensitive tumors.”
The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. The designation allows manufacturers to qualify for various incentives, including tax credits for qualified clinical trials and — upon regulatory approval — 7 years of market exclusivity.
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