Market Authorizations: RUBRACA, TAFINLAR/MEKINIST, PARTOSURE Test, CALA One

INDICATION FOR USE: Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy Complementary diagnostic test, FoundationFocusTM CDx BRCA LOH, for tumor samples to determine  homologous recombination deficiency (HRD) status. EFFICACY: Randomized, double-blind, n=561, with recurrent epithelial ovarian, fallopian tube, or primary … Continue reading Market Authorizations: RUBRACA, TAFINLAR/MEKINIST, PARTOSURE Test, CALA One

FDA Approvals: RUBRACA & CDxBRCA test, DEXCOM G5, AEROFORM

FDA BRIEF: Week of December 19, 2016 RUBRACA (rucaparib) tablets, Clovis Oncology, Boulder, CO, USA FoundationFocus CDxBRCA test, Foundation Medicine Inc. Cambridge, MA INDICATION: Monotherapy for patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies. Select patients for therapy based on an FDA-approved companion diagnostic … Continue reading FDA Approvals: RUBRACA & CDxBRCA test, DEXCOM G5, AEROFORM