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Scientific assessment report following the application for a marketing authorisation published in “ESMO Open – Cancer Horizons”
Results of phase II study with combination of two immune checkpoint inhibitors in rare subtype of melanoma
FDA also approved the PD-L1 IHC 22C3 pharmDx as a companion diagnostic
Indications concern identification of BRCA1 and/or BRCA2 mutations in ovarian cancer, PIK3CA mutations in breast cancer, ALK rearrangements in NSCLC, BRCA1, BRCA2, and/or ATM mutations in mCRPC
Results of the first phase III study to evaluate the use of the UGT1A1 genotype for guiding the irinotecan dose in this setting
Feasibility of complex, genomically guided clinical trial in oncology
Intermittent treatment does not improve progression-free survival in BRAF-mutated melanoma
NGS-based test identifies fusions in NTRK genes in DNA isolated from tumour tissue specimens
Data from the prospective genomic profiling
3-year disease-free survival rate comparable with 3- vs 6-month treatment
Efficacy was confirmed in VIALE-A and VIALE-C studies
Lenalidomide Mylan is a generic of Revlimid, which has been authorised in the EU since 2007
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