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