FDA Approves Lutathera for Some Gastro and Pancreatic Cancers

Share this content:
FDA Approves Lutathera for Some Gastro and Pancreatic Cancers
FDA Approves Lutathera for Some Gastro and Pancreatic Cancers

FRIDAY, Jan. 26, 2018 (HealthDay News) -- Lutathera (lutetium Lu 177 dotatate) is the first radioactive drug to be approved by the U.S. Food and Drug Administration to treat somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), the agency said Friday in a news release.

"GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a statement. "This approval provides another treatment choice for patients with these rare cancers."

The drug was evaluated in two clinical studies involving more than 1,400 patients. Survival with no signs of disease progression was longer for participants who received the drug than among those who didn't.

Lutathera's most common side effects included lymphopenia, high enzyme levels, vomiting, nausea, hyperglycemia, and hypokalemia. More serious adverse reactions could include myelosuppression, secondary myelodysplastic syndrome and leukemia, renal toxicity, hepatotoxicity, and infertility, the FDA said.

The drug is produced by the French firm Advanced Accelerator Applications.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

Many Foster Kids Inappropriately Prescribed Psychiatric Drugs

Many Foster Kids Inappropriately Prescribed Psychiatric Drugs

Some children may be getting meds they don't need, others may be going without drugs that may help

FDA Approves Device for Acute Coronary Artery Perforations

FDA Approves Device for Acute Coronary Artery Perforations

The PK Papyrus device is a balloon-expandable covered coronary stent and delivery system

Decrease in Infant Walker-Related Injuries Since 2010

Decrease in Infant Walker-Related Injuries Since 2010

Decrease in injuries following implementation of federal mandatory safety standard in 2010

is free, fast, and customized just for you!




Already a member?

Sign In Now »