Novel Drug Approved for HER-2 Positive Advanced Breast Cancer

By Kristin J. Kelley

Ado-trastuzumab emtansine, an antibody-drug conjugate marketed as Kadcyla, has been approved by the FDA to treat HER2-positive metastatic breast cancer. The drug — known as T-DM1 during clinical trials — is indicated for patients who didn't respond to treatment with the anti-HER2 agent trastuzumab plus chemotherapy.

In a randomized trial of nearly 1000 patients, progression-free survival was longer with T-DM1 than with lapatinib plus capecitabine (9.6 vs. 6.4 months). T-DM1 patients also had fewer grade 3 or 4 adverse events.

The drug will have a boxed warning about the potential risks for heart toxicity, liver toxicity, death, and life-threatening birth defects. Common treatment side effects include constipation, elevated liver enzymes, fatigue, muscle or joint pain, nausea, and thrombocytopenia.

The approval has been "eagerly anticipated," says Journal Watch Oncology and Hematology Editor-in-Chief Dr. William Gradishar. He says he expects that the drug will become "the preferred treatment" in eligible patients.

LINK(S):

FDA news release (Free)

Background: Journal Watch Oncology and Hematology summary on phase III trial results (Your Journal Watch subscription required)

Published in Physician's First Watch February 25, 2013