Posted from: Tuesday, January 16, 2018 - 12:29 PM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Saturday, March 24, 2018 - 03:05 PM.