Recently, Erivedge was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).

Erivedge, reviewed under the agency’s priority review program, is the first FDA-approved drug for metastatic basal cell carcinoma. Erivedge was reviewed under the FDA’s priority review program that provides for an expedited six-month review of drugs that may offer major advances in treatment. The drug is being approved ahead of the March 8, 2012, prescription user fee goal date.

Basal cell carcinoma is generally a slow growing and painless form of skin cancer that starts in the top layer of the skin (epidermis). The cancer develops on areas of skin that are regularly exposed to sunlight or other ultraviolet radiation.

Erivedge is a pill taken once a day and works by inhibiting the Hedgehog pathway, a pathway that is active in most basal cell cancers and only a few normal tissues, such as hair follicles.

“Our understanding of molecular pathways involved in cancer, such as the Hedgehog pathway, has enabled the development of targeted drugs for specific diseases,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approach is becoming more common and will potentially allow cancer drugs to be developed more quickly. This is important for patients who will have access to more effective therapies with potentially fewer side effects.”

The safety and effectiveness of Erivedge was evaluated in a single, multi-center clinical study in 96 patients with locally advanced or metastatic basal cell carcinoma.

The clinical study’s primary endpoint was objective response rate (ORR) or the percentage of patients who experienced complete and partial shrinkage or disappearance of the cancerous lesions after treatment. Of the patients with metastatic disease receiving Erivedge, 30 percent experienced a partial response and 43 percent of patients with locally advanced disease experienced a complete or partial response.

The most common side effects observed in patients treated with Erivedge were muscle spasms, hair loss, weight loss, nausea, diarrhea, fatigue, distorted sense of taste, decreased appetite, constipation, vomiting, and loss of taste function in the tongue.

Erivedge is being approved with a boxed warning alerting patients and health care professionals of the potential risk of death or severe birth effects to a fetus (unborn baby). Pregnancy status must be verified prior to the start of Erivedge treatment. Male and female patients should be warned about these risks and the need for birth control.

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��P�� lse’s mistake. “Tattoo Nightmares” is created by Sally Ann Salsano (“Jersey Shore”) and 495 Productions.

“Rat Bastards” – An invasive species of giant swamp rats are ravaging America’s Southern wetlands and are especially dangerous to the tenuous ecological system of the Mississippi delta region.  This non-scripted series follows a pack of industrious guys dubbed the “Cajun Commandoes” in Louisiana who hunt these elusive 40-pound menaces both to sell and to eat.

These determined rat hunters compete over a limited four month window to earn big bucks by capturing these loathsome pests for a bounty.  The series is co-created by Eli Holzman and Stephen Lambert of Studio Lambert and Royal Malloy, Duke Straub andColt Straub of American Chainsaw. They are also the production team behind the upcoming Spike series, “Diamond Divers.”

Spike will also create new episodes of “World’s Wildest Police Videos,” which will give viewers access to shocking and outrageous police footage never-before-seen on television.  From high-speed car chases that turn deadly and bank robberies gone wrong to international hostage holdups, the wildest police videos from around the world are on display.

Retired Sheriff John Bunnell hosts the series that is produced by Pilgrim Studios and Pursuit Productions. Executive Producers are Pilgrim Studios’ Craig Piligian andScott Popjes, and Pursuit Productions’ Paul Stojanovich, Jr., Robert Ballantyne and John Bunnell.  The original version was created by Paul Stojanovich Sr. and aired on FOX from 1998-2002.

Spike will air a two-part special, “Urban Jungle Man,” which follows the country’s preeminent extreme animal handler, John Brennan, who rescues, captures and relocates dangerous and exotic animals in New York City’s urban jungle. This non-scripted series chronicles Brennan’s daily adventures as he runs the Urban Animal Relocation team, a privately-owned exotic and dangerous animal relocation service whose perilous missions runs the gamut from removing an alligator from a bathtub to capturing an escaped deadly python.  

Bitten or stung by nearly every animal in existence, Brennan is fearless when it comes to apprehending nature’s deadliest creatures.  “Urban Jungle Man” is produced by Asylum Entertainment and will be shot throughout the country.

Image Courtesy of   http://www.flickr.com/photos/christianacare/

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