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FDA Approval Highlights: OncLive's February Recap

In case you missed it, below is a recap of all drugs that have been approved by the FDA in February 2024. ....

University Of Chicago , United States , Los Angeles , Dana Farber Cancer Institute , New Haven , Davidm Livingston , Daniel Olson , Harriet Kluger , Rachel Kobos , Zeva Wainberg , University Of California , Translational Research , Lowe Center , European Commission , Oncology Research Development , Chen Huang Center , Oncology At Yale Cancer Center , Faculty Development , Division Of Skin , Gastrointestinal Oncology Program , Gastrointestinal Oncology Program At Moffitt Cancer Center , University Of Chicago Medical Center , Harvard Medical School , Belfer Center , Metastatic Pancreatic , Oncology Program ,

Teclistamab Approved for Biweekly Dosing in R/R Multiple Myeloma

The bispecific antibody is used to treat patients with relapsed or refractory multiple myeloma (R/R MM) who have achieved and maintained a complete response for at least 6 months; this approval allows a dosing frequency of 1.5 mg/kg every 2 weeks. ....

United States , Johnson Teclistamab , Rachel Kobos , Oncology Research Development , Oncology Research , Johnson Innovative Medicine , Multiple Myeloma ,

FDA Approves Bi-weekly Teclistamab Dosing for Relapsed/Refractory Multiple Myeloma

The FDA has approved a supplemental Biologics License Application for teclistamab-cqyv (Tecvayli) at a reduced dose of 1.5 mg/kg every 2 weeks in patients with relapsed/refractory multiple myeloma who have achieved and maintained a complete response or greater for at least 6 months. ....

Rachel Kobos , Oncology Research Development , Biologics License Application , Oncology Research , Johnson Innovative Medicine ,

FDA Approves sBLA For Reduced Dosing Frequency of Teclistamab-cqyv for Patients With RRMM

Teclistamab was previously approved in October 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma who received at least 4 prior therapies. ....

Rachel Kobos , Janssen Biotech Inc , Oncology Research Development , Janssen Biotech , Biologics License Application , Oncology Research , Johnson Innovative Medicine ,

Biweekly Dosing Approved for Tecvayli in Relapsed/Refractory Multiple Myeloma

The new biweekly dosing regimen for Tecvayli is intended for patients with RRMM who have achieved and maintained a complete response or better for a minimum of 6 months. ....

Rachel Kobos , Drug Administration , Oncology Research Development , Vice President , Oncology Research , Johnson Innovative ,