By JENNIFER CORBETT DOOREN and RON WINSLOW
The Food and Drug Administration approved a new type of drug developed by the U.S. unit of Roche Holding AG to treat advanced cases of basal-cell skin cancer, the most common type of skin cancer.
The drug, known by its generic name vismodegib, will be sold under the brand name Erivedge and will be marketed in the U.S. by Genentech Inc. The drug will cost $7,500 for a monthly supply of once-a-day capsules.
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Erivedge targets what researchers call the hedgehog pathway, a channel that cells use to communicate. The channel is thought to play a role in several cancers. It?s a hot area of research, with Pfizer Inc., Bristol-Myers Squibb Co. and Novartis SA among the companies developing drugs in this category.
Last week, Infinity Pharmaceuticals Inc., of Cambridge Mass., halted efforts to develop a hedgehog drug for pancreatic cancer following disappointing results in a midstage study. The company is continuing trials of the drug in two other, rare cancers.
The hedgehog pathway got its name from geneticists who thought embryos of fruit flies with mutant forms of the gene associated with the pathway looked like they had tiny hairs sticking out of them, resembling hedgehogs.
Estimates are that as many as three million people are diagnosed with basal-cell carcinoma world-wide each year, including two million in the U.S. The cancer starts in the top layer of skin. Most cases are curable with a simple surgical procedure when the lesions are small. Genentech said there aren?t reliable estimates for how many patients progress to a point where treatment with Erivedge would be appropriate.
Erivedge is meant for use in patients with locally advanced basal-cell cancer who aren?t candidates for surgery or radiation. It also is meant for patients whose cancer has spread to other parts of the body, a condition known as metastatic cancer. The FDA said Erivedge is the first FDA-approved drug for metastatic basal-cell carcinoma. Biological pathways are how genes and proteins share information that regulates cell growth and other functions. Prenatally, the hedgehog pathway plays a crucial role in embryonic development, including the proper separation of the brain into two halves.
?The reason you have two eyes is hedgehog activity,? said Frederic J. de Sauvage, a senior scientist who championed development of the drug at Genentech.
In adults the pathway is less active, but in recent years, researchers have linked its malfunction?due to mutations and other mechanisms?to several cancers, including basal-cell carcinoma and a rare brain tumor that generally affects children called medulloblastoma.
After Dr. de Sauvage confirmed the promise of hedgehog during several years of basic research, Genentech entered a collaboration agreement with Curis Inc., Lexington Mass., which was involved in the drug?s development and will receive royalties from sales.
Genentech discovered the drug that emerged from the collaboration and initial human studies began in 2007. One of the first patients treated, who had failed other medicines and was about to go to hospice care, had a remarkably positive response, Dr. de Sauvage said. ?That was the instance I realized it would work? in people, he said.
The drug?s approval was based on a study involving 96 patients with locally advanced or metastatic basal-cell carcinoma. The study showed tumors shrank in 43% patients, or 27 out of 63, with locally advanced basal-cell cancer. About 30% patients, or 10 out of 33, with metastatic cancer responded to the drug.
While duration of treatment would vary, Genentech estimates patients would be on Erivedge for about 10 months, meaning the total course of treatment would average $75,000.
Common side effects seen with Erivedge include muscle spasms, hair loss, changes in taste, weight loss and nausea. The product will carry the FDA?s toughest boxed warning discussing a risk of death or severe birth defects to an unborn baby. Doctors need to verify female patients aren?t pregnant before starting the drug.
Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com and Ron Winslow at ron.winslow@wsj.com
Source: http://downtowncanyonville.com/fda-approves-skin-cancer-drug
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