FDA has approved Genentech’s humanized monoclonal antibody Perjeta (pertuzumab), a new anti-HER2 therapy, to treat patients with HER2-positive late-stage (metastatic) breast cancer. Perjeta was reviewed under the agency’s priority review program, which provides for an expedited six-month review of drugs that may offer major advances in treatment.
However, there are production issues that potentially could affect the long-term supply of the drug, and FDA limited its approval to drug product that has not been affected by those issues. Genentech, has, of course, committed to take steps designed to resolve these production issues in a timely manner.
The issue, according to Patrick Y. Yang, Ph.D., Genentech’s head, Pharma Global Technical Operations is related to……… Read the rest in our June weekly issue01; to subscribe: http://bioquality.biz/newsletter.htm