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FDA grants priority review for HER-2–positive breast cancer treatment
The FDA granted priority review for pertuzumab as part of combination therapy for HER-2–positive breast cancer.
Pertuzumab (Omnitarg, Genentech) is an HER-2–positive dimerization inhibitor.
The proposed indication is pertuzumab in combination with trastuzumab (Herceptin, Genentech) and docetaxel chemotherapy for patients with previously untreated HER-2–positive metastatic breast cancer or locally recurrent unresectable breast cancer, as well as for patients whose disease relapsed after adjuvant therapy.
A final decision is expected June 8.
“We are pleased that the FDA has granted pertuzumab a priority review because new medicines are needed for HER-2–positive breast cancer,” Hal Barron, MD, chief medical officer and head of global product development for Genentech, said in a press release. “We have been researching HER-2–positive breast cancer for more than 30 years, and we hope an expedited review will help us quickly bring another personalized medicine to people battling this aggressive disease.”
The FDA based its decision on Phase 3 results of the Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) study.
The international, randomized, double blind, placebo-controlled study enrolled 808 people with previously untreated HER-2–positive metastatic breast cancer. Patients were randomly assigned to a pertuzumab-trastuzumab-docetaxel regimen or to trastuzumab, chemotherapy and placebo. The primary endpoint was PFS.
Patients who received the pertuzumab-trastuzumab-docetaxel regimen had a median PFS of 18.5 months, compared with 12.4 months for those who received trastuzumab and docetaxel alone, according to study results.
Rates of grade-3 or higher neutropenia were higher in the combination arm (48.9% vs. 45.8%). Patients in the group assigned to trastuzumab and docetaxel alone demonstrated higher rates of grade-3 or higher febrile neutropenia (13.8% vs. 7.6%) and diarrhea (7.9% vs. 5.0%).
Earn CME this spring at the HemOnc Today Breast Cancer Review & Perspective meeting to be held March 23-24, 2012 at the Hilton San Diego Bayfront. See details at HemOncTodayBreastCancer.com.
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I am encouraged by the decision of the FDA to review these data promptly. Although we have made a lot of progress managing patients with HER-2–positive advanced breast cancer, more work remains. The strategies include adding anti-HER-2 therapies to other systemic therapies, which in this particular case applies to pertuzumab. It also will be very important to continue evaluation of trastuzumab-emtansine (T-DM1), as this other agent also appears to be better than docetaxel plus trastuzumab in a randomized phase 2 study, now pending corroboration in the phase 3 MARIANNE trial.
Edith A. Perez, MD
HemOnc Today Editorial Board member
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