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New FDA Guidance Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle. ....

Marjoriee Zettler , Drug Administration , Oncologic Drugs Advisory Committee , Regor Pharmaceuticals Inc , Drug Administration Expedited Development , Us Government Accountability Office , Oncology Center , Drug Administration Accelerated Approval Of Malignant Hematology , Regor Pharmaceuticals , Project Confirm , Reduce Risk , Require Stronger Evidence Of Safety And , Drug Omnibus Reform Act , Consolidated Appropriations Act , Mantle Cell Lymphoma , Marginal Zone Lymphoma , Participants With , Refractory Mantle Cell Lymphoma , Tyrosine Kinase Inhibitor , Subjects With , Refractory Marginal Zone , Tyrosine Kinase Inhibitor Ibrutinib Given , Combination With Bendamustine , Patients With Newly Diagnosed Mantle Cell , Untreated Mantle Cell , Combination With Either Bendamustine ,

New FDA Guidance Clinical Trial Considerations To Support Accelerated Approval Of Oncology Therapeutics

On April 6, 2023, AbbVie announced that it was voluntarily withdrawing ibrutinib, which was granted accelerated approval for two indications: mantle. ....

Marjoriee Zettler , Oncologic Drugs Advisory Committee , Drug Administration , Us Government Accountability Office , Drug Administration Accelerated Approval Of Malignant Hematology , Oncology Center , Drug Administration Expedited Development , Regor Pharmaceuticals Inc , Regor Pharmaceuticals , Project Confirm , Reduce Risk , Require Stronger Evidence Of Safety And , Drug Omnibus Reform Act , Consolidated Appropriations Act , Mantle Cell Lymphoma , Marginal Zone Lymphoma , Participants With , Refractory Mantle Cell Lymphoma , Tyrosine Kinase Inhibitor , Subjects With , Refractory Marginal Zone , Tyrosine Kinase Inhibitor Ibrutinib Given , Combination With Bendamustine , Patients With Newly Diagnosed Mantle Cell , Untreated Mantle Cell , Combination With Either Bendamustine ,