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FDA grants priority review to breast-cancer therapy pertuzumab
FDA has granted priority review to pertuzumab (Genentech, a member of the Roche Group) in combination with trastuzumbab (Herceptin, Genentech) and docetaxel chemotherapy for certain breast-cancer patients.
FDA has granted priority review to pertuzumab (Genentech, a member of the Roche Group) in combination with trastuzumbab (Herceptin, Genentech) and docetaxel chemotherapy for certain breast-cancer patients.
The treatment is aimed at patients with HER2-positive metastatic or locally recurrent, unresectable breast cancer who have not received previous treatment or whose disease has relapsed after adjuvant therapy.
FDA confirmed the action date is June 8.
"We have been researching HER2-positive breast cancer for more than 30 years, and we hope an expedited review will help us quickly bring another personalized medicine to people battling this aggressive disease," Hal Barron, MD, chief medical officer and head, Genentech Global Product Development, said in a company press release.
The pertuzumab application is based on results from the pivotal phase 3 CLEOPATRA study. The study demonstrated a 6.1-month improvement in median progression-free survival (PFS) for people who received a pertuzumab-based regimen (pertuzumab combined with Herceptin and docetaxel chemotherapy) compared to those who received Herceptin and chemotherapy alone (median PFS 18.5 vs 12.4 months). People who received the combination also experienced a 38% reduction in the risk of their disease worsening or death (HR=0.62; P<.0001), according to independent review.
Adverse events (AEs) were consistent with those seen in previous studies of pertuzumab and Herceptin, either in combination or alone. Rates of Grade 3 or higher AEs with more than 2% difference between arms were observed for neutropenia, febrile neutropenia, and diarrhea with 48.9%, 13.8%, and 7.9% in the pertuzumab, Herceptin, and chemotherapy arm compared with 45.8%, 7.6%, and 5% in the Herceptin plus chemotherapy arm, respectively.
The pertuzumab-based regimen was not associated with a higher incidence of cardiac AEs or left ventricular dysfunction compared with Herceptin and chemotherapy. Left ventricular dysfunction occurred in 8.3% of people in the Herceptin and chemotherapy arm and 4.4% of people in the pertuzumab, Herceptin, and chemotherapy arm.
Pertuzumab is a humanized monoclonal antibody being studied in early and advanced stages of HER2-positive breast cancer and advanced HER2-positive gastric cancer. The HER2 dimerization inhibitor is unique in that it is designed specifically to prevent the HER2 receptor from pairing (dimerizing) with other HER receptors (EGFR/HER1, HER3, and HER4), a process that is believed to play a critical role in the growth and formation of several different cancer types.
By preventing receptor pairing, pertuzumab is thought to block cell signaling, which may inhibit cancer cell growth or lead to the death of the cancer cell. Binding of pertuzumab to HER2 may also signal the body's immune system to destroy the cancer cells.
Coalition promotes important acetaminophen dosing reminders
November 18th 2014It may come as a surprise that each year Americans catch approximately 1 billion colds, and the Centers for Disease Control and Prevention estimates that as many as 20% get the flu. This cold and flu season, 7 in 10 patients will reach for an over-the-counter (OTC) medicine to treat their coughs, stuffy noses, and sniffles. It’s an important time of the year to remind patients to double check their medicine labels so they don’t double up on medicines containing acetaminophen.
Support consumer access to specialty medications through value-based insurance design
June 30th 2014The driving force behind consumer cost-sharing provisions for specialty medications is the acquisition cost and not clinical value. This appears to be true for almost all public and private health plans, says a new report from researchers at the University of Michigan Center for Value-Based Insurance Design (V-BID Center) and the National Pharmaceutical Council (NPC).
Management of antipsychotic medication polypharmacy
June 13th 2013Within our healthcare-driven society, the increase in the identification and diagnosis of mental illnesses has led to a proportional increase in the prescribing of psychotropic medications. The prevalence of mental illnesses and subsequent treatment approaches may employ monotherapy as first-line treatment, but in many cases the use of combination of therapy can occur, leading to polypharmacy.1 Polypharmacy can be defined in several ways but it generally recognized as the use of multiple medications by one patient and the most common definition is the concurrent use of five more medications. The presence of polyharmacy has the potential to contribute to non-compliance, drug-drug interactions, medication errors, adverse events, or poor quality of life.
Medical innovation improves outcomes
June 12th 2013I have been diagnosed with stage 4 cancer of the pancreas, a disease that’s long been considered not just incurable, but almost impossible to treat-a recalcitrant disease that some practitioners feel has given oncology a bad name. I was told my life would be measured in weeks.
