New Skin Cancer Drug Receives FDA Approval in Only 5 Years
June 13, 2012 6:47 PM
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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 9:37:15 AM
In that vein of thought, it seems odd to me that drugs that treat terminal illnesses are not approved faster. Seems like there isn't much worse alternative to slow and painful death, regardless of side effects. If the drug is shown to treat the illness, I say let people have it if they want to try it.
RE: Side effects include
6/14/2012 11:17:09 AM
That makes sense for those people who's bodies are ravaged by cancer and have months to live. In those cases, if they want to volunteer for last chance testing they should be able to.
In many cases the prime test subjects are not those whose bodies are full of cancer cancer and have only months to live. The prime targets are many times those in the earlier stages of cancer, so they still have multiple treatment options. Taking an experimental drug that harms them does them no good if there are other treatment options.
There's a balance to be weighed between the number of options a patient has, their likelihood of success and which experimental options make sense. To be sure, there are drug companies that would prey on people's hopes, make false assertions, etc. just to get them into their experimental testing, so some caution is required.
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