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 - October 2, 2018

Meeting Key Challenges in the Diagnosis and Treatment of Cutaneous T-Cell Lymphoma

We are pleased to announce the release of a seminal white paper titled Meeting Key Challenges in the Diagnosis and Treatment of Cutaneous T-Cell Lymphoma: Highlights from an Expert Roundtable, which includes highlights from a virtual roundtable comprising a panel of 6 internationally renowned experts convened to gain insight into key challenges in the diagnosis and treatment of patients with cutaneous T-cell lymphoma (CTCL).

Uncategorized - January 5, 2016

Trabectedin: a DNA-Binding Agent That Covalently Interacts with the Minor Groove of the DNA Double Helix

Trabectedin (ET-743) is a marine alkaloid isolated from the Caribbean tunicate Ecteinascidia turbinata, with a chemical structure characterized by 3 fused tetrahydroisoquinoline rings.1 Trabectedin binds to the minor groove of DNA and alkylates guanine at the N2 position, bending the helix toward the major groove.2,3 In this manner, it is [ Read More ]