FDA Approves Rituxan Plus Chemotherapy for Certain Pediatric Hematologic Cancers
The approval was based on data from the open-label, randomized phase 3 Inter-B-NHL Ritux 2010 trial.
Oncology
Cytalux Approved to Detect Ovarian Cancer Lesions During Surgery
Cytalux is a fluorescent drug intended to assist surgeons in identifying ovarian cancer lesions.
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.
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 women with recurrent or metastatic cervical cancer.
Cabometyx Approved for Radioactive Iodine-Refractory Differentiated Thyroid Cancer
The approval was based on data from the phase 3 COSMIC-311 study.
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.
Brukinsa Approved for Waldenström Macroglobulinemia
The approval was based on data from the phase 3 ASPEN trial.
Keytruda Gets Full Approval for First-Line Advanced Urothelial Carcinoma
The full approval was based on data from the confirmatory phase 3 KEYNOTE-361 trial.
Tecentriq Indication for Triple-Negative Breast Cancer Withdrawn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.
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