New Indication for Perjeta
December 20, 2017 – The U.S. FDA has approved a new indication for Perjeta® (pertuzumab), manufactured by Genentech, as an adjuvant treatment in combination with Genentech’s Herceptin® (trastuzumab) and chemotherapy for patients who have HER2-positive early breast cancer with a high risk of recurrence. Treatment should occur after surgical removal of tumors.
The new indication is based on the results of a clinical study involving 4,804 patients with HER2-positive early breast cancer who underwent surgical removal of their tumors. The use of Perjeta in conjunction with Herceptin and chemotherapy reduced the risk of invasive recurrence of the breast cancer or death of the patient by 18% compared to Herceptin and chemotherapy alone.
Perjeta is available in 420mg/14mL single-dose vials. Recommended dosing is based on indication. The drug is also approved, in combination with Herceptin and docetaxel, for the treatment of metastatic HER2-positive breast cancer in patients who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease. The FDA has also granted full approval for Perjeta to be used as a neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early stage breast cancer (either >2cm in diameter or node positive) as part of a complete treatment regimen for early breast cancer.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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