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April 2020 News Updates

Updated: Apr 23


For HER2 Positive MBC: In April 2020, the FDA approved the combination of the oral drug Tukysa (Tucatinib) with Xeloda (capecitabine) and Herceptin (or an approved biosimilar) for HER2 positive MBC patients (including those with brain metastases) who received one or more HER2-directed therapies in the metastatic setting. Approval was based upon the results of the HER2CLIMB clinical trial in which HER2 positive MBC patients, including patients with brain metastases (40% of which were untreated, or treated and progressing), were randomized to receive either the triplet of Tukysa in combination with Xeloda and Herceptin, or the doublet of Xeloda and Herceptin. The Overall Survival (OS) rate at 2 years was 44.9% for patients in the triplet arm vs. 26.6% in the doublet arm, and the median OS was 21.9 months vs. 17.4 months, respectively. The overall and progression-free survival results were consistent across all prespecified subgroups based upon age, race, hormone receptor status, geographic location, and other factors.From: https://www.healio.com/hematology-oncology/breast-cancer/news/online/%7Be214fc90-55f9-43da-996c-adc16f7bae11%7D/fda-approves-tukysa-as-part-of-combination-therapy-for-breast-cancer


For TNBC: In April 2020, the FDA-approved Trodelvy for the treatment of adult TNBC MBC patients who have received at least two prior therapies for their metastatic disease. Trodelvy, which is administered intravenously, consists of the chemotherapy drug irinotecan linked with an antibody targeted against a cell-surface protein that is expressed in more than 90% of TNBC. Approval was based upon a Phase 1/2 trial of 108 TNBC MBC patients with a median of three prior lines of therapy (80% of whom had visceral metastases). The results of the study determined that the median Progression-Free Survival (PFS) was 5.5 months and the median Overall Survival (OS) was 13.0 months. From: https://www.oncnursingnews.com/web-exclusives/fda-approves-sacituzumab-govitecan-for-triplenegative-breast-cancer


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