FDA Looks To Pediatric Oncology Subcommittee For Trial Advice, But Gets Little Clarity
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US FDA's latest BTD awards go to Seattle Genetics and Astellas' antibody-drug conjugate for immunotherapy-experienced urothelial cancer, Fennec's supportive care product to reduce cisplatin ototoxicity in pediatric cancer patients, and Bristol's double immunotherapy combo in MSI-H colorectal cancer.
As the message that pediatric trials may be necessary or required has apparently gotten across to industry, ODAC’s Pediatric Subcommittee is ready to advise developers on trials that might help improve the way pediatric cancer drugs are developed. Nominations are being accepted for its December meeting.
The company reported difficulties combining the drug with other chemotherapies in adults, but FDA's pediatric oncology subcommittee says that may not be the case in children.