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

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 of PERJETA?

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. These reactions may be severe, may happen quickly, and may affect many areas of the body

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 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 docetaxel as part of an early breast cancer regimen before surgery are:

• Hair loss
• Low levels of white blood cells with or without fever
• Diarrhea
• Nausea

The most common side effects of PERJETA when given with Herceptin and docetaxel following 3 cycles of epirubicin, cyclophosphamide, and fluorouracil as part of an early breast cancer regimen before surgery are:

• Diarrhea
• Nausea
• Hair loss
• Low levels of white blood cells with or without fever
• Vomiting
• Feeling tired

The most common side effects of PERJETA when given with Herceptin, docetaxel, and carboplatin as part of an early breast cancer regimen before surgery are:

• Diarrhea
• Hair loss
• Low levels of white blood cells with or without fever
• Nausea
• Feeling tired
• Vomiting
• Low levels of red blood cells
• Low platelet count

The most common side effects of PERJETA when given with Herceptin and paclitaxel following 4 cycles of dose-dense doxorubicin and cyclophosphamide as part of an early breast cancer regimen before surgery are:

• Nausea
• Diarrhea
• Hair loss
• Feeling tired
• Constipation
• Damage to the nerves (numbness, tingling, pain in hands/feet)
• Headache

The most common side effects of PERJETA when given with Herceptin and docetaxel following 4 cycles of epirubicin, cyclophosphamide, and fluorouracil as part of an early breast cancer regimen before surgery are:

• Diarrhea
• Nausea
• Hair loss
• Weakness
• Constipation
• Feeling tired
• Mouth blisters or sores
• Vomiting
• Pain in the muscles
• Low levels of red blood cells

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 1-800FDA-1088 or 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