BETHESDA, MD 11 June 2012—FDA and Genentech on June 8 announced the approval of pertuzumab injection as part of a treatment regimen for patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
Pertuzumab, which will be sold as Perjeta, should be used in combination with trastuzumab and docetaxel for the treatment of metastatic breast cancer.
Genentech expects the new product to be available to U.S. patients within two weeks. But the company stated that it is working to resolve a production problem that could affect the future availability of pertuzumab.
The FDA-approved labeling (PDF) for pertuzumab describes it as a recombinant humanized monoclonal antibody that inhibits the dimerization of HER2 with related cell-surface receptors. This inhibitory action is believed to be detrimental to the growth of tumor cells, according to the labeling.
A boxed warning in the labeling states that fetal exposure to pertuzumab may cause serious birth defects or fetal death. Women should use appropriate contraception during pertuzumab treatment and for six months after receiving their last dose.
The recommended initial dosage of pertuzumab is 840 mg administered as a 60-minute i.v. infusion. Subsequent treatments should occur every three weeks and consist of 420 mg infused intravenously over 30–60 minutes.
If a dose is delayed or missed and the time between two sequential infusions is less than six weeks, the patient should receive 420 mg of pertuzumab as soon as possible and not wait for the next planned dose.
If more than six weeks elapse between doses, the patient should receive 840 mg of pertuzumab and then 420 mg at three-week intervals.
The labeling provides the recommended dosages of trastuzumab and docetaxel when those drugs are administered concurrently with pertuzumab.
Each preservative-free, single-use vial of pertuzumab contains 420 mg of the drug at a concentration of 30 mg/mL. The vials should be refrigerated at 4–8 °C until use.
To prepare pertuzumab for infusion, withdraw the appropriate volume from the vial and dilute it into a 250-mL infusion bag containing 0.9% sodium chloride. Mix gently. Do not add other drugs to the infusion solution.
The solution should be infused immediately but can be refrigerated for up to 24 hours if immediate use is not possible.
In clinical trials, the most common adverse events reported by patients treated with pertuzumab in combination with trastuzumab and docetaxel were diarrhea, hair loss, neutropenia, nausea, fatigue, rash, and peripheral neuropathy.
Infusion reactions and hypersensitivity reactions, including anaphylaxis, were also associated with the administration of pertuzumab.