FDA Approves New Treatment Option for Adjuvant Treatment of Specific Type of Early Breast Cancer

December 20th, 2017

On December 20, 2017, the FDA approved Perjeta^® (pertuzumab), in combination with Herceptin^® (trastuzumab) and chemotherapy (the Perjeta-based regimen), for adjuvant (after surgery) treatment of HER2-positive early breast cancer at high risk of recurrence.

News in brief

• The approval is based on results of the Phase III APHINITY study, which showed adjuvant treatment with Perjeta, Herceptin and chemotherapy significantly reduced the risk of invasive breast cancer recurrence or death compared to Herceptin and chemotherapy alone.
• Despite significant advances in the treatment of HER2-positive early breast cancer, there is still a chance that cancer cells may remain in the body after surgery, and the cancer may return.
• The goal of treating early breast cancer after surgery is to reduce the risk of the cancer coming back.
• The FDA has also converted the previously granted accelerated approval of the Perjeta-based regimen to full approval for neoadjuvant (before surgery) treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either greater than two centimeters in diameter or node-positive).

Supporting Information

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