Click Here to
Subscribe
Breaking
News, Updates,
& More
Stay Up
to Date

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

Web Exclusives - Breast Cancer, FDA Updates, In the News
Yvette Florio Lane

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.

Related Items
November 11, 2019 — Oncology News & Updates
Web Exclusives published on November 11, 2019 in FDA Updates, In the News
Zejula Receives FDA Approval for HRD-Positive Advanced Ovarian Cancer
Web Exclusives published on November 7, 2019 in FDA Updates, Ovarian Cancer
November 4, 2019 — Oncology News & Updates
Web Exclusives published on November 5, 2019 in Financial Toxicity, Head and Neck Cancer, Hematologic Cancers, In the News, Leukemia
Nubeqa New Oral Therapy FDA Approved for Nonmetastatic Prostate Cancer
Web Exclusives published on October 29, 2019 in FDA Updates
Turalio First FDA-Approved Systemic Therapy for Tenosynovial Giant-Cell Tumor
Web Exclusives published on October 29, 2019 in FDA Updates
Rozlytrek Third FDA-Approved Tumor-Agnostic Drug and Second Treatment for Patients with NTRK Fusion Tumors
Web Exclusives published on October 29, 2019 in FDA Updates
Adding CDK4/6 Inhibitor to Endocrine Therapy Improves Survival in Advanced Breast Cancer: New Standard of Care
Phoebe Starr
Web Exclusives published on October 28, 2019 in ESMO, Breast Cancer
October 28, 2019 – Oncology News & Updates
Web Exclusives published on October 28, 2019 in FDA Updates, In the News, Ovarian Cancer
Vincristine, Racial Disparities in Multiple Myeloma, and HER2 Metastatic Breast Cancer Are in the News
Web Exclusives published on October 22, 2019 in Breast Cancer, FDA Updates, In the News, Multiple Myeloma, Pediatric Cancer
FDA on In Vitro Diagnostics, Vaping; Cost of Novel Treatments
Web Exclusives published on October 15, 2019 in FDA Updates, In the News, NCCN
Last modified: May 14, 2019