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

Doctors nudged by overdose letter prescribe fewer opioids

August 9, 2018
In a novel experiment, doctors got a letter from the medical examiner's office telling them of their patient's fatal overdose. The response: They started prescribing fewer opioids.

Unwise opioids for wisdom teeth: Study shows link to long-term use in teens and young adults

August 7, 2018
Getting wisdom teeth removed may be a rite of passage for many teens and young adults, but the opioid painkiller prescriptions that many of them receive could set them on a path to long-term opioid use, a new study finds.

Benzodiazepine and related drug prescriptions have increased among young people in Sweden

August 7, 2018
The prevalence rate of prescriptions for benzodiazepines and benzodiazepine-related drugs (BZD)—medications used to treat anxiety, insomnia, epilepsy and other neuropsychiatric conditions—increased by 22% between 2006 ...

Behavioral nudges lead to striking drop in prescriptions of potent antipsychotic

August 1, 2018
A study led by Columbia University's Mailman School of Public Health has found that letters targeting high prescribers of Seroquel (quetiapine), an antipsychotic with potentially harmful side effects in the elderly, significantly ...

US opioid use not declined, despite focus on abuse and awareness of risk

August 1, 2018
Use of prescription opioids in the United States has not substantially declined over the last decade, despite increased attention to opioid abuse and awareness of their risks, finds a study published by The BMJ today.

Methadone linked to lower death rates among convicted offenders with opioid dependence

July 31, 2018
Among convicted offenders, receiving methadone is associated with lower rates of death from external and non-external causes, according to new research published this week in PLOS Medicine by Angela Russolillo of Simon Fraser ...

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.