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Randy Dotinga is a medical writer based in San Diego, Calif.
A newly approved medication called sonidegib (Odomzo) gives physicians a second option in a class of medications designed to treat a small number of patients who suffer from locally advanced basal cell carcinoma and meet other criteria. Learn more
A newly approved medication called sonidegib (Odomzo) gives physicians a second option in a class of medications designed to treat a small number of patients who suffer from locally advanced basal cell carcinoma and meet other criteria.
The drug is extremely expensive, at around $10,000 a month, and linked to several side effects. But it offers patients an alternative to the similar drug vismodegib (Erivedge), which can prompt resistance over time, says David J. Leffell, M.D., professor and chief of Dermatologic Surgery & Cutaneous Oncology at Yale School of Medicine.
“The results are pretty good with vismodegib, and I’d suspect the results for the Novartis drug (sonidegib) will be similar or better,” he says. “It’s always better to have two arrows in your quiver than one.”
At issue: locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy or is present in patients who aren’t candidates for surgery or radiation therapy.
According to the American Cancer Society, about 2.8 million cases of basal cell carcinoma are diagnosed in the U.S. each year, although the number of patients is smaller since some have more than one lesion.
The FDA approved vismodegib (manufactured by Genentech) as a treatment in 2012, followed by sonidegib in 2015. Both drugs work by suppressing the molecular Hedgehog pathway, which plays a role in the development of basal cell cancers.
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Dr. Leffell hasn’t prescribed sonidegib yet, but he has had success at his practice with vismodegib, the existing drug. It’s been a “godsend” for patients with excessive number of basal cell tumors or ones that are inoperable, he says.
“I’ve been impressed by how well the patients have tolerated it relative to the benefits they’ve gotten,” he says. “It can be provided by a primary dermatologist, and managing the side effects has been straightforward.”
While these tumors generally aren’t fatal, they can be destructive, such as when basal cell carcinoma has infiltrated into the eye socket, the ear or a joint, he says. According to Dr. Leffell, patients may develop these conditions because they neglect to get their tumors treated.
Another group of patients can benefit, Dr. Leffell says, are those who have a genetic condition that causes hundreds of basal cell carcinoma lesions. For them, he says, surgery is impractical.
In one case, he says, the drug has dramatically slowed or stopped the development of lesions in a man who’s suffered from dozens if not hundreds of them. He has had side effects of hair loss.
However, there’s a hitch to treatment: “When you stop the medication, the cancer can come back,” Dr. Leffell says. We’ve experienced that in certain patients.”
How can dermatologists choose which medication to use for patients who meet the criteria? “Both medicines are good options,” says Glen J. Weiss, M.D., MBA, director of Clinical Research and Phase I & II Clinical Trials, Cancer Treatment Centers of America at Western Regional Medical Center. “While these medicines have not been compared head-to-head, they are likely to yield similar results. The choice may come down to selecting for the lowest out-of-pocket patient expenses for these medicines.”
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According to goodrx.com, both sonidegeb and vismodegib cost about the same at major chain pharmacies: In the range of $10,700-$11,200 for 30 capsules with coupons or discounts. Financial assistance is available.
Side effects of sonidegeb include adverse muscoloskeltal reactions, which affected 68 percent of patents treated. Nine percent reporting reactions of grade 3 or 4. Other reactions occurred in more than 10 percent of patients: muscle spasms, alopecia, bad taste in the mouth, fatigue, nausea, musculoskeletal pain, diarrhea, decreased weight, decreased appetite, muscle pain, abdominal pain, headache, pain, vomiting, and severe itching. Laboratory tests showed that at least 5 percent of patients had elevated levels of serum creatine kinase and lipase.
Another potential side effect of both drugs: Harm to an unborn baby. The medications should not be used in women who are pregnant or planning a pregnancy, says Allen E. Bale, M.D., professor of Genetic at Yale University School of Medicine.
“The origin of hedgehog inhibitors for cancer comes from studies of the natural substance cyclopamine from the corn lily plant. Pregnant female sheep eating this plant had offspring with cyclopia, like the Greek Cyclops but also with terrible brain malformations,” he says. “This birth defect can be caused by inactivating mutations in the sonic hedgehog gene and likewise by chemicals that block the hedgehog pathway.”
DISCLOSURES: Dr. Leffell will be conducting a case-study review for Novartis. Dr. Weiss discloses that he has served on speaker’s bureaus for Pfizer, Novartis, Medscape, Merck and Amgen over the past 24 months. Dr. Bale has no disclosures.
David J. Leffell, M.D., professor and chief of Dermatologic Surgery & Cutaneous Oncology at Yale School of Medicine. 203-785- 3466, email@example.com.
Glen J. Weiss, M.D., MBA, director of Clinical Research and Phase I & II Clinical Trials, Cancer Treatment Centers of America at Western Regional Medical Center. (623) 207-3000, Glen.Weiss@ctca-hope.com
Allen E. Bale, M.D. Professor of Genetics, Yale University School of Medicine. 203-785-5749, firstname.lastname@example.org