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
This article is over a month old, voting and posting comments is disabled
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!
"The Space Elevator will be built about 50 years after everyone stops laughing" -- Sir Arthur C. Clarke
New Rogue Gene Offers Insight on How to Stop Cancer from Spreading
January 24, 2011, 9:04 AM
Scientists Working on Cancer Treatment Using Salmonella Bacteria
August 12, 2010, 10:10 AM
Creationists are Mad About Google Doodle Depicting Evolution
November 24, 2015, 8:48 PM
DHS and TSA: Whoops, We Missed That 73 Airport Employees May be Terrorists
November 19, 2015, 2:16 PM
Star Wars Spinoff Film "Rogue One", Theme Park Attractions Announced
August 17, 2015, 12:20 PM
SpaceX Falcon 9's Seventh Supply Mission to ISS Ends w/ Fiery Stage 1 Explosion
June 28, 2015, 1:10 PM
Cool Science Video: Glowing Millipede Prowls the Nevada Desert
May 18, 2015, 12:00 PM
Newly Discovered Costa Rican Glass Frog is Kermit's Doppelgänger
April 22, 2015, 11:26 AM
Most Popular Articles
Smart Security Cameras: 5 Good Choices For Any Budget
July 25, 2016, 7:13 PM
2017 Porsche Panamera: I’ll Take Three of These.
July 24, 2016, 6:44 PM
Free Windows 10 offer ends July 29th, 2016: 10 Reasons to Upgrade Immediately
July 22, 2016, 9:19 PM
Top 5 Smart Watches
July 21, 2016, 11:48 PM
5 Excellent Cable Modems: Buy Your Own and Avoid Rental Fees
July 28, 2016, 8:44 PM
Latest Blog Posts
Sceptre Airs 27", 120 Hz. 1080p Monitor/HDTV w/ 5 ms Response Time for $220
Dec 3, 2014, 10:32 PM
Costco Gives Employees Thanksgiving Off; Wal-Mart Leads "Black Thursday" Charge
Oct 29, 2014, 9:57 PM
"Bear Selfies" Fad Could Turn Deadly, Warn Nevada Wildlife Officials
Oct 28, 2014, 12:00 PM
The Surface Mini That Was Never Released Gets "Hands On" Treatment
Sep 26, 2014, 8:22 AM
ISIS Imposes Ban on Teaching Evolution in Iraq
Sep 17, 2014, 5:22 PM
More Blog Posts
Copyright 2016 DailyTech LLC. -
Terms, Conditions & Privacy Information