On Monday, the Food and Medication Administration approved the first drug for an advanced form of the most prevalent type of skin cancer.
Genentech’s Erivedge was authorized for adults with basal cell carcinoma. cell carcinoma that has progressed to other parts of the body, or those who are not candidates for the standard treatments of surgery or radiation.
According to the Food and Drug Administration, basal cell carcinoma is a slow-growing and painless type of cancer that develops on sun-exposed skin, such as the face. If it is limited to a small area of the skin, surgery and radiation treatment are generally considered curative.
However, in some cases, the tumors cannot be treated in this manner. They invade nearby tissues and can become disfiguring in some cases, known as locally advanced disease. In some cases, they become metastatic and spread throughout the body.
The F.D.A. said in a news release that the approval was based on a study of 96 patients with locally advanced or metastatic basal cell carcinoma in a clinical trial Thirty percent of individuals with metastatic illness had a partial shrinking of their tumors. 43 percent of individuals with locally advanced illness experienced either total or partial shrinkage.
There was no placebo group in the trial, and the FDA emphasized that the drug was approved after a quick review and prior to its commercialization. March 8 deadline.
Some patient advocates have pressed the FDA, claiming that it requires too much data to approve cancer treatments, potentially enabling individuals to die. Others, however, argue that the FDA must maintain a high standard to ensure that pharmaceuticals are actually safe and effective and do not provide false hope.
These disagreements culminated in November with the agency’s decision to revoke the approval for another Genentech drug, Avastin, as a breast cancer treatment..
According to a Genentech spokeswoman, the wholesale price of Erivedge will be $7,500 per month, or around $75,000 for the 10-month course of treatment that was average in the clinical trial.
The company did not mention the price in its news release announcing the approval. That seems to be a fairly common practice among drug companies, perhaps to deflect attention from the costs of medicines.
According to the FDA, erivedge can cause birth abnormalities or stillbirths. The most prevalent side effects were muscle spasms, hair loss, nausea, diarrhea, and taste difficulties.
Erivedge, also known as vismodegib, is a once-daily pill. Genentech created Erivedge with the assistance of Curis, a small firm in Lexington, Massachusetts, which will get a $10 million payment for the approval as well as a minor royalty on medicine sales.
Curis shares, which had been climbing in recent months, were down 7% to $4.80 as of 3:30 p.m. Monday.
Erivedge works by attaching to a protein called Smoothened, which inhibits the Hedgehog signaling pathway. According to Genentech, the Hedgehog pathway is vital in regulating growth and development early in childhood but becomes less active in age. However, signaling in this pathway is usually aberrant in basal cell cancer.
On Friday, Another company, Infinity Pharmaceuticals, halted a midstage trial of a Hedgehog pathway inhibitor it was developing to treat pancreatic cancer after patients who received the drug outlived those who received a placebo. But the company said it would continue to test the drug, saridegib, for other types of cancer.