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

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
Lynparza First Targeted Therapy Approved for Metastatic Prostate Cancer with HRR Mutation
Web Exclusives published on May 26, 2020 in FDA Updates, Prostate Cancer
Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
Web Exclusives published on May 26, 2020 in FDA Updates, Lung Cancer
FDA News
TOP - May 2020, Vol 13, No 3 published on May 21, 2020 in FDA Updates
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
Web Exclusives published on May 18, 2020 in FDA Updates, Lung Cancer
Tabrecta First FDA-Approved Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping
Web Exclusives published on May 11, 2020 in FDA Updates
Retevmo First Therapy Approved for 3 Types of Cancers with RET Mutations
Web Exclusives published on May 11, 2020 in FDA Updates
FDA Approves Darzalex Faspro as Subcutaneous Formulation for All Patients with Multiple Myeloma
Web Exclusives published on May 5, 2020 in FDA Updates
Zejula First PARP Inhibitor Approved as First-Line Maintenance Treatment for All Patients with Ovarian Cancer
Web Exclusives published on May 4, 2020 in FDA Updates
FDA Approves New 400 mg Every-6-Weeks Dosing Regimen of Keytruda for All Indications
Web Exclusives published on April 30, 2020 in FDA Updates
Jelmyto First FDA-Approved Therapy for Low-Grade Upper-Tract Urothelial Cancer
Web Exclusives published on April 21, 2020 in FDA Updates, Urothelial Cancer
Last modified: April 27, 2020