Imbruvica approved for mantle cell lymphoma

November 13, 2013

(HealthDay)—Imbruvica (ibrutinib) has been approved by the U.S. Food and Drug Administration to treat mantle cell lymphoma (MCL), a rare but aggressive form of blood cancer.

MCL represents about six percent of non-Hodgkin lymphoma cases, the agency said Wednesday in a news release. By the time it's usually diagnosed, it has spread to other areas such as the lymph nodes or bone marrow.

Imbruvica, designed to inhibit an enzyme that cancer cells need to spread, was granted the FDA's rare "breakthrough therapy" status as a drug that promises to offer a "substantial improvement over available therapies for patients with serious or life-threatening diseases," the agency said.

Imbruvica was evaluated in a study of 111 participants. Of those who took the drug daily, 66 percent had their cancer shrink or disappear, the FDA said. The most common side effects included: low blood platelets, diarrhea, low , anemia, fatigue, musculoskeletal pain, swelling and .

Imbruvica is co-marketed by Sunnyvale, Calif.-based Pharmacyclics, and Raritan, N.J.-based Janssen Biotech.

Explore further: New drug treatment for form of lethal cancer is approved

More information: To learn more about non-Hodgkin lymphoma, visit Medline Plus.

Related Stories

New drug treatment for form of lethal cancer is approved

July 6, 2013
A new drug has been approved to battle mantle cell lymphoma, an aggressive cancer often fatal because of its resistance to treatment, after a study led by a Hackensack University Medical Center physician showed it can stop ...

Pomalyst approved for advanced multiple myeloma

February 9, 2013
(HealthDay)—Pomalyst (pomalidomide) has been approved by the U.S. Food and Drug Administration to treat cases of multiple myeloma that have not responded to other therapies.

Drug shows surprising efficacy as treatment for chronic leukemia, mantle cell lymphoma

June 19, 2013
Two clinical studies published in the New England Journal of Medicine with an accompanying editorial suggest that the novel agent ibrutinib shows real potential as a safe, effective, targeted treatment for adults with chronic ...

Xgeva approved for rare, non-malignant tumor

June 13, 2013
(HealthDay)—Xgeva (denosumab) has been approved by the U.S. Food and Drug Administration to treat giant cell tumor of the bone (GCTB), a rare tumor that's most often non-cancerous.

Ibrutinib continues strong showing against mantle cell lymphoma

June 19, 2013
In a major international study led by researchers at The University of Texas MD Anderson Cancer Center, the targeted therapy ibrutinib continues to show remarkable promise for the treatment of relapsed or refractory mantle ...

Synribo approved to treat rare leukemia

October 26, 2012
(HealthDay)—Synribo (omacetaxine mepesuccinate) has been approved by the U.S. Food and Drug Administration to treat a rare blood and bone marrow disease called chronic myelogenous leukemia (CML).

Recommended for you

Fighting opioid addiction in primary care—new study shows it's possible

October 18, 2017
For many of the 2 million Americans addicted to opioids, getting good treatment and getting off prescription painkillers or heroin may seem like a far-off dream.

With no morphine, 25 million die in pain each year: report

October 13, 2017
Every year, some 25 million people—one in ten of them children—die in serious pain that could have been alleviated with morphine at just a few cents per dose, researchers said Friday.

Study finds few restrictions on Rx opioids through Medicare

October 9, 2017
Medicare plans place few restrictions on the coverage of prescription opioids, despite federal guidelines recommending such restrictions, a new Yale study finds. The research results highlight an untapped opportunity for ...

Nocebo effect: Does a drug's high price tag cause its own side effects?

October 5, 2017
Pricey drugs may make people more vulnerable to perceiving side effects, a new study suggests—and the phenomenon is not just "in their heads."

Pre-packaged brand version of compounded medication to prevent preterm births costs 5,000 percent more

October 2, 2017
Preventing a preterm birth could cost as little as $200 or as much as $20,000, depending on which one of two medications a doctor orders, according to a new analysis from Harvard Medical School.

Cancer drugs' high prices not justified by cost of development, study contends

September 12, 2017
(HealthDay)— Excusing the sky-high price tags of many new cancer treatments, pharmaceutical companies often blame high research and development (R&D) costs.

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.