Eisai Makes Oncology Debut With Halaven, But Development Question Marks Remain
This article was originally published in The Pink Sheet Daily
Executive Summary
Already in the small minority of drugs to gain approval via overall survival, Eisai's ability to gain additional indications for Halaven may hinge on improving the drug's progression-free survival data.
You may also be interested in...
Eisai Will Try For Halaven Label Expansion, Despite Phase III Failure
Even though Eisai’s Halaven showed an unprecedented overall survival effect in a very tough-to-treat breast cancer population, the drug appears to have flopped in a head-to-head study against Xeloda in an earlier line of therapy. Nevertheless, Eisai vows to pursue a regulatory filing that would expand the drug’s label, as planned.
Eisai Will Try For Halaven Label Expansion, Despite Phase III Failure
Even though Eisai’s Halaven showed an unprecedented overall survival effect in a very tough-to-treat breast cancer population, the drug appears to have flopped in a head-to-head study against Xeloda in an earlier line of therapy. Nevertheless, Eisai vows to pursue a regulatory filing that would expand the drug’s label, as planned.
Nektar Readies Phase III Breast Cancer Trial Of NKTR-102, On Its Own
Nektar Therapeutics Inc. will launch the Phase III BEACON trial by the end of this year for its NKTR-102, a next-generation version of the now generic topoisomerase 1 inhibitor irinotecan (Pfizer Inc.’s Camptosar). The trial, in pretreated metastatic breast cancer patients, will have a raft of endpoints designed to help gain acceptance in the crowded field.