Odomzo approved for recurring basal cell carcinoma

July 25, 2015

(HealthDay)—Odomzo (sonidegib) has been approved by the U.S. Food and Drug Administration to treat basal cell carcinoma skin cancer that has returned despite surgery or radiation.

The treatment is sanctioned for people who are not candidates for additional surgery or radiation.

Basal cell carcinoma accounts for about 80 percent of skin cancers that are not melanoma, a more deadly form of the disease. Basal cell starts in the top layer of skin, usually in areas that are most exposed to the sun, the agency said Friday in a news release.

The once-daily pill is designed to inhibit a process that promotes the growth of .

The drug's label includes a boxed warning that it may cause death or severe birth defects in a growing fetus. Women who may become pregnant should verify pregnancy status before taking the drug. And both males and females who take Odomzo are advised to use contraception, the agency said.

The drug was evaluated in a clinical study involving 66 people. Some 58 percent of people treated with 200 milligrams of Odomzo had their tumors shrink or disappear, the FDA said. The most common side effects included , hair loss, distorted taste, fatigue, nausea, muscle and bone pain, diarrhea and weight loss. More serious musculoskeletal issues also are possible.

Odomzo is marketed by Novartis, based in East Hanover, N.J.

Explore further: FDA approves Roche skin cancer drug Erivedge

More information: The FDA has more about this approval.

Related Stories

FDA approves Roche skin cancer drug Erivedge

January 30, 2012
(AP) -- Federal regulators on Monday approved a pill that treats the most common type of skin cancer, basal cell carcinoma.

Mekinist plus tafinlar approved for late-stage melanoma

January 10, 2014
(HealthDay)—The U.S. Food and Drug Administration on Friday approved Mekinist for use with another drug, Tafinlar, to treat advanced melanoma that is spreading or cannot be removed by surgery.

Orbactiv approved for drug-resistant skin infections

August 7, 2014
(HealthDay)—The antibacterial drug Orbactiv (oritavancin) has been approved by the U.S. Food and Drug Administration to treat drug-resistant skin infections in adults, the agency said in a news release.

Afinitor approved for advanced breast cancer

July 23, 2012
(HealthDay) -- Afinitor (everolimus) has been approved in combination with the drug exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer, the U.S. Food and Drug Administration ...

Opdivo approval expanded to include lung cancer

March 4, 2015
(HealthDay)—U.S. Food and Drug Administration approval of Opdivo (nivolumab) has been expanded to include advanced non-small cell lung cancer (NSCLC), the agency said Wednesday in a news release.

Farydak approved for multiple myeloma

February 24, 2015
(HealthDay)—Farydak (panobinostat) has been approved by the U.S. Food and Drug Administration to treat multiple myeloma, a cancer of the blood.

Recommended for you

Researchers publish study on new therapy to treat opioid use disorder

May 22, 2018
Better delivery of medications to treat opioid use disorder (OUD) is key to addressing the opioid crisis and helping the 2.6 million Americans affected by the disease.

Could nonprofit drug companies cut sky-high prices?

May 17, 2018
(HealthDay)—Generic prescription drugs should be cheap, but prices for some have soared in the United States in recent years. Now a group of U.S. hospitals thinks it has a solution: a nonprofit drug maker.

Fewer antibiotics for kids, but more ADHD drugs

May 15, 2018
(HealthDay)—American kids are taking fewer prescription medications these days—but certain drugs are being prescribed more than ever, a new government study finds.

Opioid makers' perks to docs tied to more prescriptions

May 14, 2018
Doctors who accept perks from companies that make opioid painkillers are more likely to prescribe the drugs for their patients, new research suggests.

Less is more when it comes to prescription opioids for hospital patients, study finds

May 14, 2018
In a pilot study published in JAMA Internal Medicine, Yale researchers significantly reduced doses of opioid painkillers given to hospital patients. By delivering the opioids with a shot under the skin or with a pill instead ...

Generic options provide limited savings for expensive drugs

May 7, 2018
Generic drug options did not reduce prices paid for the cancer therapy imatinib (Gleevec), according to a Health Affairs study released today in its May issue.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.