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FDA Approves First Antibody-Drug Conjugate in HER2-Positive Metastatic Breast Cancer

February 22nd, 2013

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.

Full Prescribing Information, including Boxed WARNINGS

Read the press release


Supporting Information


Understanding Antibody-Drug Conjugates

ADCs combine three components to provide a unique treatment option.

Roles of the HER2 Family Medicines

Learn 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

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

KADCYLA is not the same medicine as trastuzumab (Herceptin).

Liver Problems

  • KADCYLA may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), 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, rapid weight gain of greater than 5 lbs in less than 24 hours, dizziness or loss of consciousness, or irregular heartbeat

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 7 months after your last dose of KADCYLA
  • If you are exposed to KADCYLA during pregnancy or become pregnant within 7 months of your last dose of KADCYLA, contact your healthcare provider right away; you are also encouraged to enroll in the MotHER Pregnancy Registry by calling 1-800-690-6720
  • You are also encouraged to report exposure to KADCYLA during pregnancy, or if you become pregnant within 7 months of your last dose to Genentech by calling 1-888-835-2555
  • If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping KADCYLA

Contact your doctor right away if you experience symptoms associated with these 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

Serious Bleeding

  • KADCYLA can cause life-threatening bleeding. Taking KADCYLA with other medications used to thin your blood (antiplatelet) or prevent blood clots (anticoagulation) can increase your risk of bleeding. Your doctor should provide additional monitoring if you are taking one of these other drugs while on KADCYLA. Life-threatening bleeding may also happen with KADCYLA even when blood thinners are not also being taken

Low Platelet Count

  • Low platelet count may happen during treatment with KADCYLA. Platelets help your blood to clot. Signs of low platelets may include easy bruising, bleeding, and prolonged bleeding from cuts. In mild cases there may not be any symptoms

Nerve Damage

  • Symptoms may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, 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

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, because benefit has been shown only in patients whose tumors are HER2-positive.

What are the most common side effects of KADCYLA?

The most common side effects seen in people taking KADCYLA are:

  • Tiredness
  • Nausea
  • Pain that affects the bones, muscles, ligaments, and tendons
  • Bleeding
  • Low platelet count
  • Headache
  • Liver problems
  • Constipation
  • Nosebleeds

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.

Fred Jacobson

“Our scientists have worked for more than a decade to refine the sophisticated science and manufacturing technology of our first ADC, so it is an incredible honor to now make Kadcyla a reality for people with this aggressive form of breast cancer.”