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 5, 2016

Dabrafenib plus Trametinib: Two Kinase Inhibitors Used in Combination to Target Different Parts of the MAPK Pathway

The MAPK pathway is constitutively activated in the majority of melanomas as a result of molecular alterations in genes encoding key components of the pathway (eg, BRAF and NRAS mutations) or upstream cell surface receptors (eg, KIT), resulting in uncontrolled tumor proliferation and survival (Figure 1).1 Among patients with metastatic [ Read More ]

FDA Approvals, News & Updates, Web Exclusives - November 13, 2019

November 11, 2019 — Oncology News & Updates

  • FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
  • Trump Will Nominate Dr Hahn as Next FDA Commissioner
  • Researchers Report High Rates of E-Cigarette Use Among Children and Teens