FDA Approves Erivedge to Treat Most Common Skin Cancer - Basal Cell Carcinoma
About a million cases of basal cell carcinoma in U.S. each year with senior citizens prominent victims; most common of
Feb. 1, 2012 - Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration this week for the treatment of
adults with basal cell carcinoma, the most common type of skin cancer, and should be available in pharmacies within two weeks. Senior citizens
are at high risk of these cancers. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for
surgery or radiation and for those 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
Basal cell carcinoma is generally considered curable if the cancer is restricted to a small area of the skin, according
to the website of Genentech, a member of the Roche Group based in San Francisco, that will market
Couples encouraged to examine each other for
suspicious moles that could be skin cancer. Researchers estimate that 40
– 50% of people in the U.S. who live to age 65 will have nonmelanoma
skin cancer at least once.
In rare cases, lesions can become disfiguring and invade surrounding tissue (locally advanced) or spread to other parts
of the body (metastasize). In these cases of advanced BCC, the disease cannot be effectively treated with surgery or radiation. Advanced BCC
often results in severe deformity or loss of function of affected organs.
"Today's approval provides a new treatment for people with advanced basal cell carcinoma who, until now, had no approved
medicines to help shrink disfiguring or potentially life-threatening lesions," said Hal Barron, M.D., chief medical officer and head, Global
"We are pleased that in the last six months we have been able to provide two new medicines for different types of
advanced skin cancer to people who previously had few or no treatment options."
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.
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 capsule taken orally 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.
For more information:
>> For more information about Erivedge distribution in the United States, doctors can contact
Erivedge Access Solutions online or call 1-888-249-4918. Erivedge Access
Solutions also provides doctors and patients coverage and reimbursement support, patient assistance and information resources.
The FDA, an agency within the U.S. Department of Health and Human Services, reports it protects the public health by
assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and
medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating tobacco products.
About Basal Cell Cancer
Nodular basal cell carcinoma, a type of basal cell carcinoma that appears as a well-defined growth with rolled edges. It
may be pigmented or translucent with visible blood vessels. Also known as cystic basal cell carcinoma, it usually appears on the face.
More at American Academy of Dermatology
Skin cancer is the most common form of cancer in the U.S. The two most common types are basal cell cancer and squamous
cell cancer. They usually form on the head, face, neck, hands and arms. Another type of skin cancer,
melanoma, is more dangerous but less common.
Anyone can get skin cancer, but it is more common in people who
● Are over age 50
● Spend a lot of time in the
sun or have been sunburned
● Have light-colored skin, hair and eyes
● Have a family member with skin cancer
You should have your doctor check any suspicious skin markings and any changes in the way your skin looks. Treatment is
more likely to work well when cancer is found early. If not treated, some types of skin cancer cells can spread to other tissues and organs.
When seen under a microscope, these cancers share features with the cells in the lowest layer of the epidermis, called
the basal cell layer.
About 8 out of 10 skin cancers are basal cell carcinomas (also called basal cell cancers). They usually develop on
sun-exposed areas, especially the head and neck. Basal cell carcinoma was once found almost exclusively in middle-aged or older people. Now it
is also being seen in younger people, probably because they are spending more time in the sun with their skin exposed.
Basal cell carcinoma tends to be slow growing. It is very rare for a basal cell cancer to spread to nearby lymph nodes or
to distant parts of the body. But if a basal cell cancer is left untreated, it can grow into nearby areas and invade the bone or other tissues
beneath the skin.
After treatment, basal cell carcinoma can recur (come back) in the same place on the skin. People who have had basal cell
cancers are also more likely to get new ones elsewhere on the skin. As many as half of the people who are diagnosed with one basal cell cancer
will develop a new skin cancer within 5 years.
What should I look for?
Basal and squamous cell cancers
Basal cell cancers and squamous cell cancers are most often found in areas that get exposed to a lot of sun, such as the
head, neck, and arms, but they can occur elsewhere. Look for new growths, spots, bumps, patches, or sores that don't heal after 2 to 3 months.
Basal cell carcinomas often look like flat, firm, pale areas or small, raised, pink or red, translucent, shiny, waxy
areas that may bleed after a minor injury. They may have one or more abnormal blood vessels, a lower area in their center, and/or blue, brown,
or black areas. Large basal cell carcinomas may have oozing or crusted areas.
Squamous cell carcinomas may look like growing lumps, often with a rough, scaly, or crusted surface. They may also look
like flat reddish patches in the skin that grow slowly.
Both of these types of skin cancer may develop as a flat area showing only slight changes from normal skin.
Actinic keratosis, also known as solar keratosis, is a skin condition that is sometimes pre-cancerous and is caused by
too much sun exposure. Actinic keratoses are usually small (less than ¼ inch across), rough spots that may be pink-red or flesh-colored.
Usually they develop on the face, ears, back of the hands, and arms of middle-aged or older people with fair skin, but they can occur in
younger people or on other sun-exposed areas of the skin. People with one actinic keratosis usually develop many more. Some can grow into
squamous cell cancers, but others may stay the same or even go away on their own. These areas can turn cancerous and should be looked at by a
doctor, who can help determine if they should be treated.