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 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 and sometimes fatal 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