Drug News

In 2013, the FDA granted accelerated approval to pertuzumab (Perjeta) as the first neoadjuvant treatment for early-stage breast cancer in patients with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer at risk of recurrence or metastasis. This approval was based on a study with 417 patients, where approximately 39% achieved pathologic complete response (pCR) with the pertuzumab regimen, compared to 21% with trastuzumab and docetaxel alone. Common side effects included alopecia, diarrhea, nausea, and neutropenia. A confirmatory trial with over 4,800 participants was underway, with results expected by 2016. Additionally, a meta-analysis of randomized clinical trials involving 6,735 patients suggested that influenza vaccination could lower the risk of cardiovascular events, especially in high-risk patients with recent acute coronary syndromes. Concerns were raised about the safety of expedited drug approvals by the FDA, as a study of 20 drugs approved in 2008 showed many safety questions remained unanswered. A trial with 300 patients indicated that statin therapy did not improve 28-day mortality in patients with ventilator-associated pneumonia (VAP), leading to the trial's early termination. Lastly, the FDA approved Vizamyl (flutemetamol F 18 injection) for PET imaging to detect beta amyloid in the brain for dementia assessment, with effectiveness confirmed in two studies with 384 patients, although a positive scan does not definitively diagnose Alzheimer's disease.