FDA Approves Farydak for Multiple Myeloma

Share this content:
FDA Approves Farydak for Multiple Myeloma
FDA Approves Farydak for Multiple Myeloma

(HealthDay News) -- Farydak (panobinostat) has been approved by the U.S. Food and Drug Administration to treat multiple myeloma. Farydak inhibits the activity of histone deacetylases, which could slow the overproduction of plasma cells among people with multiple myeloma, the FDA said.

The new drug is sanctioned for people who have received at least two prior standard therapies. It's approved to be given in combination with two other drugs, bortezomib and dexamethasone. The safety and effectiveness of Farydak in combination with bortezomib and dexamethasone were evaluated in clinical studies involving 193 people with multiple myeloma. People who received the three-drug combination saw a delay in disease progression of about 10.6 months, compared with 5.8 months among people who received the other two drugs alone.

In November, an FDA advisory committee recommended against approving Farydak for people with relapsing multiple myeloma, saying its benefits did not outweigh its risks. But the drug's maker, Novartis, subsequently submitted additional information supporting the drug's use for people with multiple myeloma who had received at least two prior standard therapies, the FDA said.

Farydak's label includes a boxed warning of the potential for fatal or severe heart problems, and severe diarrhea, the FDA said. More common and less severe reactions could include diarrhea, fatigue, nausea, swelling of the extremities, loss of appetite, fever, vomiting and weakness.

Novartis is based in East Hanover, N.J.

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

Ground Beef Recalled After E. Coli Outbreak

Ground Beef Recalled After <i>E. Coli</i> Outbreak

Beef was produced and packaged at Cargill Meat Solutions in Fort Morgan, Colo.

Prevalence of Alzheimer's, Related Dementia Set to Double

Prevalence of Alzheimer's, Related Dementia Set to Double

Alzheimer's disease and related dementias burden is expected to increase to 3.3 percent in 2060

Long-Term Outcomes of Breast Implants Explored

Long-Term Outcomes of Breast Implants Explored

Higher rates of Sjogren syndrome, scleroderma, RA, stillbirth, melanoma for silicone implants

is free, fast, and customized just for you!




Already a member?

Sign In Now »