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Perjeta Approved For HER2-Positive Metastatic Breast Cancer

June 8th, 2012

On June 8, 2012, Perjeta® (pertuzumab) was approved in combination with Herceptin® (trastuzumab) and docetaxel chemotherapy for the treatment of people with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy for metastatic breast cancer.

The combination of Perjeta, trastuzumab and docetaxel chemotherapy was the only regimen to significantly extend the time people with previously untreated HER2-positive metastatic breast cancer lived without their disease worsening (progression-free survival or PFS) compared to trastuzumab plus docetaxel chemotherapy (6.1 month improvement in median PFS, 18.5 vs. 12.4 months).


Full Prescribing Information including Most Serious Side Effects

Read the press release


 

Important Safety Information and Serious Side Effects

What should I know about side effects with PERJETA?

  • Not all people have serious side effects; however, side effects with PERJETA therapy are common. It is important to know what side effects may happen and what symptoms you should watch for
  • Your doctor may stop treatment if serious side effects happen. Be sure to contact your healthcare team right away if you have questions or are worried about any side effects

What are the most serious side effects?

PERJETA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure).

  • Your doctor may run tests to monitor your heart function before and during treatment with PERJETA
  • Based on test results your doctor may hold or discontinue treatment with PERJETA

Receiving PERJETA during pregnancy can result in the death of an unborn baby and birth defects.

  • Birth control should be used while receiving PERJETA and for 7 months after your last dose of PERJETA. If you are a mother who is breastfeeding, you should talk with your doctor about either stopping breastfeeding or stopping PERJETA
  • If you think you may be pregnant, you should contact your healthcare provider immediately
  • If you are exposed to PERJETA during pregnancy, or become pregnant while receiving PERJETA or within 7 months following the last dose of PERJETA in combination with Herceptin, you are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720 or visiting http://www.motherpregnancyregistry.com/ and report PERJETA exposure to Genentech at 1-888-835-2555

What are other possible serious side effects?

  • PERJETA should not be used in patients who are allergic to pertuzumab or to any of the ingredients in PERJETA
  • Infusion-related reactions: PERJETA is a medicine that is delivered into a vein through a needle. This process can cause reactions known as infusion-related reactions. The most common infusion-related reactions when receiving PERJETA, Herceptin, and docetaxel were feeling tired, abnormal or altered taste, allergic reactions, muscle pain, and vomiting. The most common infusion-related reactions when receiving PERJETA alone were fever, chills, feeling tired, headache, weakness, allergic reactions, and vomiting
  • Severe allergic reactions: Some people receiving PERJETA may have severe allergic reactions, called hypersensitivity reactions or anaphylaxis. This reaction may be severe, may happen quickly, and may affect many areas of the body

How will my doctor and I know if PERJETA is right for me?

PERJETA has only been shown to work in people with HER2-positive breast cancer. You must have a HER2 test to know if your breast cancer is HER2-positive before receiving an anti-HER2 treatment, such as PERJETA.

What are the most common side effects?

The most common side effects of PERJETA when given with Herceptin and docetaxel for treatment of breast cancer that has spread to other parts of the body (metastatic) are:

  • Diarrhea
  • Hair loss
  • Low levels of white blood cells with or without a fever
  • Nausea
  • Feeling tired
  • Rash
  • Damage to the nerves (numbness, tingling, pain in hands/feet)

Report side effects to Genentech and the FDA. Report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please see PERJETA full Prescribing Information including Most Serious Side Effect for additional Important Safety Information at www.perjeta.com.