FDA Approval Of Roche Cancer Drug Signals A New Paradigm

In a move that may prompt drugmakers to rethink development of cancer treatments, the FDA late yesterday approved the first medicine to treat breast cancer before surgery. Called Perjeta, the Roche biologic was endorsed as part of the accelerated approval program, occurring just three weeks after an FDA panel recommended use and a full month before the agency was expected to make a decision. The drug is intended for patients with HER2-positive, locally advanced, inflammatory or early stage breast cancer, who are at high risk of having their cancer return, spread to other parts of the body or of dying from the disease. Surgery to remove tumors is usually the first step in treating most forms of cancer, but Perjeta is the first drug approved as a pre-surgical step, making the approval significant. “We are seeing a significant shift in the treatment paradigm for early stage breast cancer," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, says in a statement. "By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences." Until recently, new breast cancer treatments were approved for patients with metastatic cancer, but use in the early stages would only occur after large randomized trials with extensive follow-up were conducted. With Perjeta, the FDA acted on the results of a recent study in 417 women that compared the...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs