FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer

Breast Cancer, FDA Approvals, News & Updates

On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).

This latest approval was based on the phase 3, multicenter, open-label KATHERINE clinical trial of 1486 patients with HER2-positive early breast cancer. Patients were randomized in a 1:1 ratio to ado-trastuzumab emtansine (3.6 mg/kg intravenously every 3 weeks) or trastuzumab (6 mg/kg intravenously every 3 weeks) for 14 cycles. Patients were required to have had neoadjuvant taxane and trastuzumab-based therapy with residual invasive tumor in the breast and/or axillary lymph nodes.

After a median follow-up of 40 months, results showed that treatment with ado-trastuzumab emtansine significantly improved invasive disease-free survival compared with trastuzumab (hazard ratio, 0.50; 95% confidence interval, 0.39-0.64; P <.0001).

The most common adverse reactions (≥25%) associated with ado-trastuzumab in patients with early breast cancer were fatigue, nausea, increased transaminases, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, peripheral neuropathy, and arthralgia.

Ado-trastuzumab emtansine was previously approved by the FDA on February 22, 2013, for the treatment of patients with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.

The recommended dose of ado-trastuzumab emtansine is 3.6 mg/kg given as an intravenous infusion, every 3 weeks (21-day cycle), until disease recurrence or unacceptable toxicity, or a total of 14 cycles for patients with early breast cancer.

Uncategorized - January 4, 2016

Can Metastatic Cancer with Diagnostic Ambiguity Be Treated Based on Mutational Status Alone?

The application of molecularly targeted cancer therapies has rapidly expanded in the past 2 decades. The identification of genetic mutations in tumors has led to a growing list of therapies developed to specifically target those alterations. Indeed, molecularly targeted therapies—along with predictive biomarker testing and site-specific chemotherapy—have significantly improved the [ Read More ]

Uncategorized - August 7, 2015

Introduction

As evidenced by the 2013 annual meetings of the American Association for Cancer Research (AACR), the American Society of Clinical Oncology (ASCO), and the European Hematology Association (EHA), the pace at which scientific knowledge is influencing cancer drug development is astounding. Breakthroughs in our collective understanding of the underlying biology [ Read More ]