regulatory approval
European Commission Approves Merck's Keytruda-Chemo Combination for Advanced TNBC Patients
The approval makes Merck's PD-1 inhibitor available to European TNBC patients whose tumors express PD-L1 with a combined positive score of at least 10.
FDA Approves Gilead's Tecartus for Acute Lymphoblastic Leukemia
The agency approved the second indication for the autologous, CD19-directed CAR T-cell therapy based on the results of the Phase I/II ZUMA-3 trial.
Pillar Biosciences Receives FDA Approval for OncoReveal Dx Lung and Colon Cancer Assay
The IVD, intended for use on the Illumina MiSeq Dx, detects somatic mutations in tumor tissue samples to guide the use of anti-EGFR therapy where indicated.
NICE Recommends Incyte's Pemazyre for FGFR2-Positive Bile Duct Cancer
The drug was approved in the UK for previously treated patients with locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement.
Merck's Keytruda Plus Chemo Approved in Europe for Certain Gastroesophageal Cancers
The European Commission approved the combination as first-line treatment for PD-L1-expressing advanced esophageal cancer or HER2-negative GEJ cancer.