FDA Approves First Antibody-Drug Conjugate in HER2-Positive Metastatic Breast Cancer
On February 22nd, 2013, the FDA approved Kadcyla™ (ado-trastuzumab emtansine), as a single medicine, for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin® (trastuzumab) and a taxane chemotherapy. People should either:
- Have already been treated for their metastatic cancer, or
- Have had their early-stage cancer come back during or within six months after they completed a course of treatment following surgery.
News in brief
- A new personalized medicine that has helped people with an aggressive form of breast cancer live longer (median overall survival 30.9 months vs. 25.1 months in Phase III study).
- An antibody-drug conjugate (ADC), a new kind of targeted medicine that can attach to certain types of cells and deliver chemotherapy directly to them.
- The fourth medicine from Genentech to receive FDA approval for people with advanced cancers within the past two years.
Roles of the HER2 Family MedicinesLearn about three personalized Genentech medicines in the HER2 Family
What is HER2-Positive Metastatic Breast Cancer?Understand metastatic, or advanced, breast cancer, which may also be HER2-positive.
Important Safety Information
Kadcyla is not the same medicine as Herceptin.
There are possible serious side effects of Kadcyla. Patients must contact their doctor right away if they experience any of these symptoms. The patient’s doctor may do tests before starting Kadcyla and before each dose to monitor for these side effects. Kadcyla treatment may be stopped or the dose may be lowered if the patient experiences any of these side effects.
- Kadcyla may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, stomach pain, dark urine or itching.
- Kadcyla may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, or rapid weight gain of greater than five pounds in less than 24 hours.
- Receiving Kadcyla during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while patients receive Kadcyla and for six months after their last dose of Kadcyla.
- If patients are exposed to Kadcyla during pregnancy, they must contact their healthcare provider right away; they are also encouraged to enroll in the MotHER Pregnancy Registry by contacting (800) 690-6720.
- If patients are mothers who are breastfeeding, they should talk with their doctor about either stopping breastfeeding or stopping treatment with Kadcyla.
Additional Possible Serious Side Effects of Kadcyla
- Kadcyla may cause lung problems, including inflammation of the lung tissue, which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness and fluid in the lungs.
- Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways or a fast heartbeat. The patient’s doctor will monitor the patient for infusion-related reactions.
Low Platelet Count
- Low platelet count may happen during treatment with Kadcyla. Platelets are cells in the blood that help the blood clot.
- Symptoms may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, or muscle weakness or loss of muscle function.
Skin Reactions Around the Infusion Site
- Kadcyla may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the infusion.
HER2 Testing and Kadcyla
Patients must have a HER2 test to determine if their cancer is HER2-positive before taking Kadcyla, as benefit has only been shown in patients whose tumors are HER2-positive.
Most Common Side Effects of Kadcyla
In clinical studies, the most common side effects seen in people taking Kadcyla were:
- Pain that affects the bones, muscles, ligaments and tendons
- Low platelet count
- Liver problems
The most common severe side effects of Kadcyla were:
- Low platelet count
- Liver problems
- Low levels of red blood cells
- Nerve problems
- Low levels of potassium in the blood
Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
For full Prescribing Information and Boxed WARNINGS on Kadcyla, please visit http://www.kadcyla.com.