Chimeric monoclonal antibody targets EGFR for the treatment of colon cancer
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.
FDA Grants Priority Review to Dupixent in COPD
If approved, this would be the sixth indication for Dupixent and the only biologic therapy for COPD. The target action date is June 27, 2024.
FDA Approves Biweekly Dosing of Tecvayli for Multiple Myeloma
Patients with multiple myeloma who switched from weekly to biweekly dosing of Tecvayli were able to maintain their response with fewer infections.
FDA Sets Review Date for Linvoseltamab for Advanced Multiple Myeloma
Linvoseltamab is bispecific antibody designed to treat relapsed/refractory multiple myeloma. The FDA’s target action date is Aug. 22, 2024
FDA Sets Date for First-in-Class Lung Cancer Therapy
If approved, datopotamab deruxtecan would be the first TROP2-directed antibody drug conjugate to treat patients with non-small cell lung cancer. The FDA’s action date is in the fourth quarter of 2024.
FDA Approves Amtagvi, the First TIL Therapy for a Solid Tumor
Amtagvi was approved to treat patients with advanced melanoma. It is a one-time cell therapy that will be administered at authorized treatment centers and have a wholesale acquisition cost of $515,000.
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