Erivedge Side Effects and Adverse Health Reactions

Erivedge Side Effects and Adverse Health Reactions. The most common cancer in Europe, Australia and the United States, basal cell carcinoma’s incidence is rising worldwide.

Each year, the disease strikes some 800,000 people in the U.S., one in seven Canadians, and 100,000 people in the United Kingdom. In Australia, incidence for superficial BCCs is 336/100,000 in men and 251/100,000 in women. Statistically, about three in every 10 Caucasians may develop a basal cell carcinoma within their lifetime.

Generally, BCCs are slow growing and painless forms of skin cancer that start in the skin’s sun-exposed top layer or epidermis.

Unlike the more deadly skin cancers melanoma and squamous cell carcinoma, BCCs are not usually fatal. But because they often grow on the face and other exposed areas, they can be horrid-looking and disfiguring. In rare cases, too, a BCC can also metastasize or spread to other parts of the body and become deadly.

Like most cancers, BCCs are more likely to be cured if they’re detected early. Early detection and treatment are key, with BCCs typically treated with simple outpatient therapies like freezing or surgically removing the cancerous area.

But sometimes—in a small fraction of patients—the BCCs prove to be stubborn and come back after surgery, or can’t be treated with radiation. Sometimes, they also metastasize.

To treat these stubborn basal cell carcinomas, specialist Swiss drug maker Genentech has come up with a new once-a-day pill called Erivedge, which U.S. federal regulators approved on Jan. 30.

Known chemically as vismodegib, Erivedge is the first drug ever approved for treating basal cell carcinoma.

The U.S. Food and Drug Administration says it’s intended for use particularly in patients with “locally advanced” and “metastatic” basal cell cancers, “who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body.”

The pill will be available in mid-February, according to Genentech, a unit of Swiss drug maker Roche.

To gain FDA approval, Genentech sponsored a single clinical study enrolling 96 patients with advanced or spreading BCC. In the study, Erivedge shrank the tumors in 30 percent of those with metastatic cancer and shrank or eliminated tumors in 43 percent of patients with locally advanced cancer.

Speedy approval but black box warning
That one study was enough for the FDA to approve Erivedge under its speediest form of review: Erivedge was given a fast six-month review—mainly because there are no approved treatments for basal cell carcinoma. So the approval comes ahead of schedule, as the FDA previously said it would make a decision on Erivedge by March 8.

But the approval comes with the FDA’s “black box” warning—it’s highest safety alert—that notes the drug carries a risk of causing stillbirth or severe birth defects.

The warning says that Erivedge cannot be used by pregnant women. And even men taking Erivedge must use condoms with spermicides—even if they have had vasectomies—to avoid unintentionally contaminating their female partners with the drug.

Basal cell carcinoma cells need a signal, called a Hedgehog, to grow, and the new cancer drug inhibits this signal.