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Perjeta Approved For HER2-Positive Metastatic Breast Cancer

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).

Read the press release

See full Prescribing Information including Most Serious Side Effect (PDF)

Fact sheets

• Perjeta in HER2-Positive Metastatic Breast Cancer
• Metastatic Breast Cancer
  

Important Safety Information and Serious Side Effects

What should patients know about side effects with Perjeta?

• Because side effects from this treatment are common, it is important to know what side effects may happen and what symptoms patients should watch for
• A patient's doctor may stop treatment if serious side effects happen. Patients must contact their healthcare team right away if they have questions or are worried about any side effects

What is the most serious side effect?

Most Serious Side Effect: 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 6 months after a patient's last dose of Perjeta. Patients who are breastfeeding should talk with their doctor about either stopping breastfeeding or stopping Perjeta
• If a patient thinks they may be pregnant they should contact their healthcare provider immediately
• If a patient is exposed to Perjeta during pregnancy, they are encouraged to enroll in the MotHER Pregnancy Registry by contacting 1-800-690-6720

What are other possible serious side effects?

• Heart problems: Perjeta can result in heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). A patientÕs doctor may run tests to monitor the patient's heart function before and during treatment with 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 (chemotherapy) were fatigue, loss of taste, allergic reactions, muscle pain, 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 doctors and patients know if Perjeta is the right treatment option?

Perjeta has been shown to work only in people with HER2-positive breast cancer. Patients must have a HER2 test to know if their 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 (chemotherapy) 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 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.

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