NEW CANCER DRUGS
Faster to US Market Than European Market
Some have criticized the US Food and Drug Administration (FDA) as slow, inefficient and risk-averse in reviewing new cancer drugs compared to its European counterpart, the European Medicines Agency (EMA). On June 16, 2011, Health Affairs of Bethesda, MD published a detailed report that compares review times at the FDA and EMA for new oncology drugs during the time span of 2003 to 2010.
The data came from public databases on both the FDA and EMA websites. They evaluated 35 drugs that were approved by either the FDA or EMA and all of the drugs that were approved by both regulatory agencies were available to patients first in the U S. The researchers found that the FDA consistently took less time than the EMA to review a new oncology drug. The median time for the FDA approval was 182 days whiie the median time for the EMA was 350 days.
TARGETED CANCER DRUGS
Offer new Therapy Options
Unlike traditional chemotherapeutic agents, which work with the whole body of cells, targeted cancer drugs block the specific pathways that cancer cells will use to grow and replicate. These targeted drug therapies were the topic of the day at the annual meeting of the American Society of Clinical Oncology in June.
The success of vemurafenib given to advanced melanoma patients was proof that targeted therapies work. Roche reported that 63 percent of melanoma patients were less likely to die than the patients given chemotherapy. Vemurafenib blocks the growth of cells with the mutation in a gene known as BRAF. About half of all melanoma patients have the genetic aberration.
GlaxoSmithKline PLC developed two experimental drugs – one a BRAF inhibitor and another designed to block cells with a gene known as MEK. The combination of these two targeted drugs shrinks tumors in the majority of patients with advanced melanoma.
Read the entire report here.
A CONSORTIUM FOR CANCER
A Five-Year International Oncology Project
On June 1, 2011, Genome Technology published the news of the formation of an international consortium of researchers managed by both Bayer HealthCare Pharmaceuticals and the Max Planck Institute for Molecular Genetics in Berlin. The Innovative Medicines Initiative, which is a public-private partnership between the pharmaceutical industry and the European Union, funds the five-year project known as Methods for Systematic Next-Generation Oncology Biomarker Development. The group calls itself OncoTrack.
“The goal of this collaboration is to generate high-quality genomic and epigenetic data from the tumors of 60 cancer patients as well as from those patients’ normal genomes.” OncoTrack involves researchers from Sweden, Germany, and London, and also the pharmaceutical companies such as AstraZeneca, Pfizer, Merck, and Roche Diagnostics.
Max Planck’s Dr. Bodo Lange says that “The OncoTrack project will revolutionize and make much more efficient the way new drugs, new targets for old drugs, and more efficient chemotherapeutic approaches are identified and brought into practical application.”
Read the entire unique proposal here.
