FDA Approves New Treatment for Acute Lymphoblastic Leukemia

Share this content:
FDA Approves New Treatment for Acute Lymphoblastic Leukemia
FDA Approves New Treatment for Acute Lymphoblastic Leukemia

THURSDAY, Aug. 17, 2017 (HealthDay News) -- The U.S. Food and Drug Administration on Thursday approved Besponsa (inotuzumab ozogamicin) to treat B-cell acute lymphoblastic leukemia (ALL).

Besponsa was evaluated in clinical studies involving 326 patients with relapsed or refractory B-cell ALL who had received one or two prior treatments with other medication. After taking Besponsa, 35.8 percent of patients evaluated achieved complete remission for about eight months, compared with 17.4 percent of those who took a different chemotherapy drug.

Common side effects of Besponsa included thrombocytopenia, neutropenia, leukopenia, infection, anemia, fatigue, and severe bleeding. The drug's label includes a boxed warning of possible severe liver damage. Pregnant or breastfeeding women shouldn't take Besponsa, the FDA said.

"For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low," Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence, said in a statement. "These patients have few treatments available and today's approval provides a new, targeted treatment option."

Approval was granted to Pfizer, based in New York City.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

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 »