New drug that helps skin cancer

Genentech Drug Shrinks Advanced Basal Cell Cancers
By Daniel J. DeNoon
Reviewed by Laura J. Martin, MD
WebMD Health News

Jan. 31, 2012 -- The FDA has approved Erivedge, a once-daily pill that can shrink disfiguring or metastatic basal cell carcinoma (BCC) tumors.

BCC, the most common form of skin cancer, usually is curable. But in rare cases, the cancer spreads through the body or invades surrounding parts of the body.

These advanced, sometimes disfiguring cancers often cannot be completely eliminated with surgery or radiation.

But BCC cancer cells need a signal, dubbed Hedgehog, to grow. Erivedge inhibits this signal.

In a single clinical study that enrolled 96 patients with advanced or spreading BCC, Erivedge shrank the tumors in 30% of those with metastatic cancer and shrank or eliminated tumors in 43% of patients with locally advanced cancer.

That was enough for the FDA to approve Erivedge under its speediest form of review.

The approval comes with the FDA's "black box" warning -- it's most severe safety alert -- noting that the drug carries a risk of causing stillbirth or severe birth defects. It cannot be used by pregnant women. Men taking Erivedge must use condoms, even if they have had vasectomies, to avoid unintentionally contaminating their female partners with the drug.

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 will be available in the U.S. within two weeks. However, it will not be sold at retail pharmacies, but must be dispensed at "specialty pharmacies" where staff is trained to offer patient education.

Erivedge is made by Genentech, a Roche company. The firm says it soon will seek approval in the European Union.
Recommended dose of ERIVEDGE is 150 mg taken orally once daily until disease progression or until unacceptable toxicity.
ERIVEDGE may be taken with or without food. Swallow capsules whole. Do not open or crush capsules.

If a dose of ERIVEDGE is missed, do not make up that dose; resume dosing with the next scheduled dose.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Erivedge:

Constipation; diarrhea; hair loss; joint pain; loss of appetite; loss of taste or other taste changes; muscle spasms; nausea; tiredness; vomiting; weight loss.

Seek medical attention right away if any of these SEVERE side effects occur when using Erivedge:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absent menstrual period; decreased urination; symptoms of low blood potassium levels (eg, muscle pain, weakness, or cramping; irregular heartbeat); symptoms of low blood sodium levels (eg, confusion, mental or mood changes, seizures, sluggishness).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.