Kadcyla Indication Expands as Adjuvant Breast Cancer Treatment
Recent trial shows greater invasive disease-free survival when treated with Kadcyla , (ado-trastuzumab emtansine)
Kadcyla, (ado-trastuzumab emtansine, Genentech, Inc.) has been approved for use as an adjuvant treatment of patients with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. It had been previously approved for patients with metastatic HER2-positive breast cancer who had prior treatment with trastuzumab and taxane chemotherapy.
The new indication for Kadcyla is based on the results of a randomized multicenter open-label trail of 1486 patients with HER2-positive EBC, the KATHERINE study. Patients received radiotherapy and/ or hormonal therapy along with study treatment per local guidelines.
The trial’s primary endpoint was invasive disease-free survival (IDFS)-the time from the date of randomization to first occurrence of ipsilateral invasive breast tumor recurrence, ipsilateral local or regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause. After a median follow-up of 40 months, patients who also received ado-trastuzumab emtansine reached a statistically significant improvement in IDFS compared with those who received trastuzumab.
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The most common adverse reactions reported during the trial were fatigue, nausea, increased transaminases, musculoskeletal pain, hemorrhage, thrombocytopenia, headache, peripheral neuropathy, and arthralgia.
Recommended starting dosage for Kadcyla is 3.6 mg/kg given as an intravenous infusion every three weeks on a 21-day cycle until disease progression, unacceptable toxicity, or for a total of 14 cycles.
Kadcycla comes with a boxed warning of hepatotoxicity, cardiac toxicity, and an embryo-fetal toxicity complication. The drug does not have any contraindications.
