Tecartus Approved for Relapsed/Refractory B-Cell Precursor Acute Lymphoblastic Leukemia
The approval was based on data from the phase 1/2 ZUMA-3 trial which evaluated Tecartus in 71 adults with relapsed or refractory B-cell precursor ALL.
Oncology
Erbitux Plus Encorafenib Approved for BRAF V600E Mutation-Positive Metastatic Colorectal Cancer
The approval is supported by data from the phase 3 BEACON CRC trial in adults with BRAF V600E mutation-positive metastatic colorectal cancer with disease progression.
Relatlimab-Nivolumab Fixed-Dose Combo Gets Priority Review for Melanoma
The application is supported by data from the phase 2/3 RELATIVITY-047 trial.
Tivdak Approved for Recurrent or Metastatic Cervical Cancer
The approval was based on data from the phase 2 innovaTV 204 trial that evaluated Tivdak as monotherapy in 101 adult females with recurrent or metastatic cervical cancer.
Exkivity Approved for EGFR Exon 20 Insertion+ NSCLC
Exkivity (mobocertinib) is approved to treat adults with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
Tislelizumab Under Review for Esophageal Squamous Cell Carcinoma
The application is supported by data from the phase 3 RATIONALE 302 trial.
FDA: New Warnings and Limitations Set for Certain JAK Inhibitors
The revisions are based on a completed review of a large randomized safety clinical trial, which included 4362 patients with rheumatoid arthritis.
Tecentriq Indication for Triple-Negative Breast Cancer Withdrawn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.
Tibsovo Approved for IDH1-Mutated Cholangiocarcinoma
The approval was based on data from the double-blind, placebo-controlled ClarIDHy study.
Tebentafusp Gets Priority Review for Metastatic Uveal Melanoma
The application is supported by data from the phase 2 IMCgp100-202 trial that assessed tebentafusp in 378 HLA-A*02:01-positive adults with previously untreated metastatic uveal melanoma.
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