Perjeta First to Gain Accelerated Approval via New FDA Pathway

Genentech’s Perjeta Sept. 30 became the first drug to win approval under the FDA’s new accelerated approval pathway carved out for early-stage breast cancer before surgery. The pathway makes the treatment available “several years earlier than previously possible,” Hal Barron, Genentech’s chief medical officer, said. The FDA in 2012 issued a draft guidance on using pathologic complete response as an endpoint to support accelerated approval of a drug for neoadjuvant treatment of high-risk, early-stage breast cancer.
Washington Drug Letter