Generic Equivalent to Istodax Now Available
Romidepsin is a histone deacetylase inhibitor indicated for the treatment of cutaneous T-cell lymphoma.
All articles by Steve Duffy
Tafinlar-Mekinist Combo Wins Tumor-Agnostic Indication for BRAF V600E Solid Tumors
The accelerated approval was based on data from two phase 2 trials: the ROAR basket study and the NCI-MATCH Subprotocol H study.
Keytruda Approved for Adjuvant Treatment IIB, IIC Melanoma Following Resection
Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
Tecentriq Indication for Triple-Negative Breast Cancer Withdrawn
In 2019, the FDA granted accelerated approval to Tecentriq, a PD-L1 blocking antibody, for unresectable locally advanced or metastatic TNBC.
FDA Grants First Full Approval to Pfizer-BioNTech COVID-19 Vaccine
The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
Ukoniq Approved for Marginal Zone Lymphoma, Follicular Lymphoma
The approval was based on data from the open-label, multi-cohort phase 2 UNITY-NHL Trial.
Enhertu Gains Gastric Cancer Indication
The approval was based on data from the phase 2 DESTINY-Gastric01 trial.
Biosimilar Riabni Gets FDA Approval
The biosimilar has been approved for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis, and Microscopic Polyangiitis.
FDA Accepts and Grants Priority Review to New sBLA for Keytruda
Results presented at the European Society for Medical Oncology Virtual Congress 2020showed significant improvements in the primary endpoints for the pembrolizumab group.
Novel Treatment Gains Accelerated Approval for Relapsed/Refractory Neuroblastoma
Approval was based on results from two phase 2 single-arm, open-label trials that demonstrated overall response rate and duration of response.
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