Kadcyla

Generic Name: ado-trastuzumab emtansine
Date of Approval: February 22, 2013
Company: Genentech, Inc.

Treatment for: Breast Cancer

FDA Approves Kadcyla

February 26, 2013 -- The U.S. Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine or T-DM1) for the treatment of people with HER2-positive metastatic breast cancer (mBC) who have received prior treatment with Herceptin (trastuzumab) and a taxane chemotherapy.

Kadcyla is an antibody-drug conjugate (ADC), a new kind of targeted cancer medicine that can attach to certain types of cancer cells and deliver chemotherapy directly to them. Kadcyla is the first FDA-approved ADC for treating HER2-positive mBC, an aggressive form of the disease.

Kadcyla is made up of the antibody, trastuzumab, and the chemotherapy, DM1, joined together using a stable linker. Kadcyla combines the mechanisms of action of both trastuzumab and DM1.

Kadcyla Patient Information

What is Kadcyla used for?

Kadcyla is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) in patients who have received prior treatment with trastuzumab (Herceptin®) and a taxane.

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What is the most important safety information I should know about Kadcyla?

Kadcyla is not the same medicine as trastuzumab (Herceptin)

There are possible serious side effects of Kadcyla. Contact your doctor right away if you experience any of these symptoms. Your 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 you experience any of these side effects.

• Liver problems
  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
• Heart problems
  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 5 lbs in less than 24 hours
• Pregnancy
  Receiving Kadcyla during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while you receive Kadcyla and for 6 months after your last dose of Kadcyla.
  If you are exposed to Kadcyla during pregnancy, contact your healthcare provider right away; you are also encouraged to enroll in the MotHER Pregnancy Registry by contacting 1 (800) 690-6720.
  If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping Kadcyla.

How will my doctor know if Kadcyla is right for me?

You must have a HER2 test to determine if your cancer is HER2-positive before taking Kadcyla, as benefit has only been shown in patients whose tumors are HER2-positive.

Kadcyla side effects

What are the additional possible serious side effects of Kadcyla?

• Lung problems
  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
• Infusion-related reactions
  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. Your doctor will monitor you for infusion-related reactions
• Low platelet count
  Low platelet count may happen during treatment with Kadcyla. Platelets are cells in your blood that help your blood clot
• Nerve damage
  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

The most common side effects seen in people taking Kadcyla were:

• tiredness
• nausea
• pain that affects the bones, muscles, ligaments, and tendons
• low platelet count
• headache
• liver problems
• constipation

The most common severe side effects of Kadcyla are:

• low platelet count
• liver problems
• low levels of red blood cells
• nerve problems
• low levels of potassium in the blood
• tiredness

You are encouraged to report side effects to Genentech and the FDA. You may contact Genentech by calling 1 (888) 835-2555. You may contact the FDA by visiting www.fda.gov/medwatch or calling 1 (800) FDA-1088.