FDA approves odomzo for recurring basal cell carcinoma

July 25, 2015

FDA approves odomzo for recurring basal cell carcinoma
Odomzo (sonidegib) has been approved by the U.S. Food and Drug Administration to treat locally advanced basal cell carcinoma that has returned despite surgery or radiation. The treatment is sanctioned for people who are not candidates for additional surgery or radiation.
(HealthDay)—Odomzo (sonidegib) has been approved by the U.S. Food and Drug Administration to treat patients with locally advanced basal cell carcinoma that has returned despite surgery or radiation, or who are not candidates for additional surgery or radiation.

The once-daily pill is designed to inhibit the Hedgehog pathway. The drug was evaluated in a clinical study involving 66 people. Fifty-eight percent of people treated with 200 mg of Odomzo had their tumors shrink or disappear, the FDA said. The most common side effects included , alopecia, dysgeusia, fatigue, nausea, myalgia, diarrhea, and weight loss. More serious musculoskeletal issues also are possible.

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.

"Thanks to a better understanding of the Hedgehog pathway, the FDA has now approved two drugs for the treatment of basal cell carcinoma just in the last three years," Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. Erivedge (vismodegib) was approved in 2012 to treat locally advanced and metastatic

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

Explore further: FDA approves Roche skin cancer drug Erivedge

More information: More Information

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.

FDA approves iressa for EGFR metastatic lung cancer

July 14, 2015
(HealthDay)—Iressa (gefitinib) has been approved by the U.S. Food and Drug Administration to treat patients with metastatic non-small-cell lung cancer (NSCLC) with a specific genetic mutation (epidermal growth factor receptor ...

Blincyto approved for rare leukemia

December 3, 2014
(HealthDay)—Blincyto (blinatumomab) has been approved by the U.S. Food and Drug Administration to treat Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia, a rare cancer of the bone marrow.

FDA approves new drug for schizophrenia, major depression

July 13, 2015
(HealthDay)—A new drug to treat schizophrenia and depression has been approved by the U.S. Food and Drug Administration.

FDA approves new skin cancer drug

February 1, 2012
A new skin cancer drug tested for the first time in the world five years ago at the Virginia G. Piper Cancer Center at Scottsdale Healthcare just received expedited approval by the U.S. Food and Drug Administration, a remarkable ...

FDA: Akynzeo approved for chemo-related nausea / vomiting

October 11, 2014
(HealthDay)—The combination drug Akynzeo (netupitant and palonosetron) has been approved by the U.S. Food and Drug Administration to treat nausea and vomiting among people undergoing chemotherapy, the agency said Friday ...

Recommended for you

Health insurer policies may discourage use of non-opioid alternatives for lower back pain

October 5, 2018
Public and private health insurance policies in the U.S. are missing important opportunities to encourage the use of physical therapy, psychological counseling and other non-drug alternatives to opioid medication for treating ...

Opioid overdoses, depression linked

October 3, 2018
The link between mental health disorders and substance abuse is well-documented. Nearly one in 12 adults in the U.S is depressed, and opioid-related deaths are skyrocketing. As these numbers continue to climb, some mental ...

Do price spikes on some generic drugs indicate problems in the market?

October 1, 2018
A new USC study reports that sudden price spikes for some generic drugs—such as the recently reported increases of a decades-old generic heart medication and an antibiotic—are becoming more common.

Reclassification recommendations for drug in 'magic mushrooms'

September 26, 2018
In an evaluation of the safety and abuse research on the drug in hallucinogenic mushrooms, Johns Hopkins researchers suggest that if it clears phase III clinical trials, psilocybin should be re-categorized from a schedule ...

New study finds concurrent use of prescription drugs and dietary supplements could pose health risks

September 25, 2018
A new University of Hertfordshire study found that using certain over-the-counter herbal medicines and dietary supplements alongside prescription drugs could pose serious health risks, especially amongst older adults.

Drug overdose epidemic has been growing exponentially for decades

September 20, 2018
Death rates from drug overdoses in the U.S. have been on an exponential growth curve that began at least 15 years before the mid-1990s surge in opioid prescribing, suggesting that overdose death rates may continue along this ...

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.