The agency says the Roche drug can be used with Herceptin and docetaxel on some patients with HER2-positive metastatic breast cancer.
HER2 protein speeds the spread of cancer. Herceptin is among the chemo drugs frequently prescribed for breast cancer patients with positive HER2 readings in combination therapy with other breast cancer drugs. (Avastin showed promise as a Herceptin partner, but was stripped of its approval as a breast cancer drug.)
Perjeta was not cleared for use in combination therapy. But on the strength of the Cleopatra study, which showed a six-month progression-free survival improvement from use of pertuzumab-trastuzumab-docetaxel (Perjeta-Herceptin-Taxotere) combination treatment over trastuzumab-docetaxel, FDA expedited review of that application. Last week they approved Perjeta's use for treatment of HER2-positive metastatic breast cancer patients who have not already received anti-HER2 therapy or chemotherapy for metastatic disease.
Update: FiercePharma reports that there are production issues with Perjeta, though Roche-Genentech says it can keep up with demand. "Shortages of life-sustaining cancer drugs have become an industry concern," writes reporter Eric Palmer, "but to essentially announce a shortage even as a potential blockbuster drug is being approved for release takes the industry into new territory."