July 2021, Vol 11, No 7

Data aggregation and management challenges for community oncology practices are becoming more complicated with the advent and application of precision medicine. As advances are made in clinical molecular technologies, and the volume, velocity, and value of this data increases, adjustments must be made to incorporate informatics approaches to inform data-driven decision-making through robust and reliable integration of multiple heterogeneous data sources into one consolidated analytics platform. Read Article ›

On May 28, 2021, the FDA granted accelerated approval to infigratinib (Truseltiq; QED Therapeutics, Inc), an oral FGFR1-3 selective inhibitor, for the treatment of adults with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) with an FGFR2 fusion or other rearrangement. The FDA previously granted infigratinib orphan drug and fast-track designations. Read Article ›

On May 28, 2021, the FDA accelerated the approval of sotorasib (Lumakras; Amgen), an oral KRAS inhibitor of the RAS GTPase family, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) associated with KRAS G12C mutation, as determined by an FDA-approved test, after ≥1 systemic therapies. The FDA granted sotorasib orphan drug and breakthrough therapy designations. Read Article ›

On May 21, 2021, the FDA accelerated the approval of amivantamab-vmjw (Rybrevant; Janssen/Johnson & Johnson), a bispecific antibody targeting mutations in the EGFR and MET pathways, for adults with non–small-cell lung cancer (NSCLC) that is associated with EGFR exon 20 insertion mutations, as detected by the FDA-approved Guardant360 CDx test, which was approved on the same day as a companion diagnostic for amivantamab. The FDA had granted amivantamab a breakthrough therapy designation for this indication. Read Article ›

On May 5, 2021, the FDA accelerated the approval of the PD-1 inhibitor pembrolizumab (Keytruda; Merck & Co), in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read Article ›

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