New Skin Cancer Drug Receives FDA Approval in Only 5 Years
June 13, 2012 6:47 PM
comment(s) - last by
Basal cell carcinoma
The drug, called Vismodegib, was first administered to a patient on January 23, 2007
drug has been labeled "the greatest advance in therapy yet seen" by the
New England Journal of Medicine
The skin cancer drug, called Vismodegib, which is being marketed as Erivedge, is intended for skin cancer patients with advanced basal cell carcinoma. It blocks the Hedgehog signaling pathway and treats locally advanced and metastatic basal cell carcinomas. It can also treat basal cell nevus syndrome, which is inherited genetic susceptibility for large basal cell carcinoma development.
Vismodegib was tested by Translational Genomics Research Institute (TGen), Mayo Clinic and Virginia G. Piper Cancer Center at Scottsdale Healthcare.
Vismodegib was first administered to a patient on January 23, 2007. It underwent a Phase 1 clinical trial at the Virginia G. Piper Cancer Center at Scottsdale Healthcare, which partnered with TGen.
"The first patient put on this drug had advanced basal cell cancer, so we suspected that the
tumor had the mutation
this drug is targeted against," said Ramesh K. Ramanathan, M.D., Medical Director at Virginia G. Piper Cancer Center Clinical Trials and Clinical Professor and Deputy Director of the Clinical Translational Research Division at TGen. "And our partnership with Dr. Ronald Korn and his team who did advanced PET imaging helped to really demonstrate the drug's efficacy for Genentech to continue pursuing the additional study."
The first phase was successful, leading to a Phase 2 clinical trial of basal cell carcinoma. Researchers at the Mayo Clinic headed this particular phase.
The success of Phase 2 led to Vismodegib's U.S. Food and Drug Administration (FDA) approval on January 30, 2012. Vismodegib is the first drug to receive FDA approval to treat inoperable basal cell carcinoma. It only took Vismodegib five years to receive FDA approval, which is impressive considering most drugs take about 15 years to achieve this.
"It is a landmark day for patients with basal cell carcinoma and all those involved in their care," said the
New England Journal of Medicine
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RE: Side effects include
6/14/2012 8:03:38 AM
Side effects are all those reported during testing, not only by the people using the drug, but by the control group of people, who are given a placebo to use (with none of the testers knowing whether they have the drug, or the placebo).
It really is sort of foolish to report the "side effects" of the placebo group in with those of the drug, but that's the way the law is written, so they have to do it.
Personally, I will welcome any such drug, as it's likely just a matter of time before I'll need it. Too many years working outside, without appreciation (until recent years) for sun block.
Also, the fact that I lost my sister to melanoma, almost 3 years ago. I would not wish that on anyone!
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