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).


 


Important Safety Information

  • PERJETA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure)
  • Receiving PERJETA during pregnancy can result in the death of an unborn baby and birth defects
    • 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
  • PERJETA should not be used in patients who are allergic to pertuzumab or to any of the ingredients in PERJETA
  • Other possible serious side effects of PERJETA therapy include:
    • Infusion-related reactions
    • Severe allergic reactions (hypersensitivity reactions/anaphylaxis)
  • 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 fever
    • Nausea
    • Feeling tired
    • Rash
    • Damage to the nerves (numbness, tingling, pain in hands/feet)
  • The most common side effects of PERJETA when given with Herceptin and chemotherapy as part of an early breast cancer regimen before surgery are:
    • Constipation
    • Damage to the nerves (numbness, tingling, pain in hands/feet)
    • Diarrhea
    • Feeling tired
    • Hair loss
    • Headache
    • Low levels of red blood cells
    • Low levels of white blood cells with or without fever
    • Low platelet count
    • Mouth blisters or sores
    • Nausea
    • Pain in the muscles
    • Vomiting
    • Weakness

Side effects may vary based on chemotherapy regimen.

  • The most common side effects of PERJETA when given with Herceptin and chemotherapy as part of an early breast cancer regimen after surgery are:
    • Diarrhea
    • Nausea
    • Hair Loss
    • Feeling tired
    • Damage to the nerves (numbness, tingling, pain in hands/feet)
    • Vomiting

You are encouraged to report side effects to Genentech and the FDA. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information, including most serious side effects