Purpose ARCHER 1050, a randomized, open-label, phase III study of dacomitinib versus gefitinib in treatment-naïve patients with advanced non–small-cell lung cancer (NSCLC) and activating mutations in EGFR, reported significant improvement in progression-free survival with dacomitinib. The mature overall survival (OS) analysis for the intention-to-treat population is presented...

Background:InO is a calicheamicin-conjugated antibody targeting CD22 on ALL blast cells. Here we report outcomes in R/R ALL patients (pts) receiving InO or standard of care chemotherapy (SC) in the phase 3 INO-VATE trial according to baseline BMB%, an indicator of disease burden.   Methods:Adults with CD22+...

Background:In the ongoing phase 3 ARCHER 1050 study, first-line treatment with daco significantly improved the primary endpoint of progression-free survival, duration of response, and time to treatment failure vs gef in patients (pts) with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer...

WEDNESDAY, NOVEMBER 1, 2017   The U.S. Food and Drug Administration (FDA) approved gemtuzumab ozogamicin (GO) for two patient populations: adults with newly diagnosed CD33-positive acute myeloid leukemia (AML) and children ≥2 years old with relapsed or refractory CD33-positive AML.   GO originally received accelerated approval in May 2000...

Background: While there is a clear consensus for defining radioiodine-refractory differentiated thyroid cancer (RR-DTC), it is unknown whether these criteria are equally valid for determining when radioiodine (RAI) therapy is no longer beneficial and systemic treatment should be considered. Lenvatinib, a multikinase inhibitor, significantly prolonged progression-free...

First kinase inhibitor to show improvement in overall survival in any patient group with RAI-R DTC Data published in the Journal of Clinical Oncology WOODCLIFF LAKE, N.J., Aug. 28, 2017 /PRNewswire/ -- Eisai Inc. announced data from a prespecified subgroup analysis, which was published in the Journal of Clinical Oncology, showing treatment with...

CAMBRIDGE, Mass., Nov. 29, 2016 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today announced that the confirmatory Phase 3 clinical study of M923, a biosimilar HUMIRA® (adalimumab) candidate developed in collaboration with Baxalta, now part of Shire plc, in patients with moderate-to-severe chronic plaque psoriasis, met its primary endpoint. The proportion...

Background:InO, an anti-CD22 antibody-calicheamicin conjugate, showed superior response vs standard care for R/R ALL in the phase III INO-VATE trial. Herein, effects of prior therapy on response and toxicities were assessed in patients (pts) receiving InO.    Methods:Per protocol, intent-to-treat analyses of complete remission [CR]/CR with incomplete...