The U.S. Food and Drug Administration (FDA) is moving towards approving a new drug for the treatment of breast cancer, reports ABC News.  The FDA’s panel of cancer experts evaluated the drug, named Perjeta and manufactured by Swiss drugmaker Roche through its holding Genentech.  The panel of 14 experts voted 13-0, with one expert abstaining from the vote.  Their vote indicated that the panel believed the benefits of Perjeta as an initial treatment for breast cancer outweigh its risks.  The FDA is not required to accept the assessment of the panel of experts or take their recommendation to approve the drug, but this vote indicates approval is likely.

Perjeta would be the first FDA-approved pharmaceutical option to shrink or eliminate tumors before surgery.  In clinical trials, Genentech found that women who used Perjeta as the initial treatment were 18 percent more likely to be cancer-free after 12 weeks.  Perjeta is currently approved to treat breast cancer that has spread to other parts of the body.  The drugmaker hopes to incorporate Perjeta into the first line of treatment.

The FDA panel chairman stated that the vote was historic because these types of drugs have the potential to reshape treatment of breast cancer as well as the results.  In particular, using the drug in the early stages could reduce tumor size and make it easier to remove the tumors.  Women may be able to avoid having a full mastectomy and be able to keep their breasts, which can make a large impact on the mental and emotional well-being of the patient.  The drug does, however, show serious side effects, including a higher rate of cardiac issues.

Perjeta is being considered for an accelerated approval, which is offered to drugs that show groundbreaking results in their early stages of testing.  However, the panel, though supportive of Perjeta, emphasized the need for Genentech to conduct more studies that specifically demonstrate that use of Perjeta increases life expectancy for patients.

Genentech has had no trouble finding women willing to enroll in clinical trials involving Perjeta.  Already, the San Francisco-based company has 4,800 patients enrolled in a large study.  The results of this study will hopefully confirm the clinical efficacy and effectiveness of Perjeta.  The panelists had pointed to deficiencies in the previous trials, including small population size.  While the previous study looked at a short-term response, it does not evaluate long-term effectiveness and impact on life expectancy.