FDA Approvals

New Treatment Approved for Deadly Blood Cancer

THURSDAY, Aug. 17, 2017 -- The U.S. Food and Drug Adminstration on Thursday approved the anti-cancer drug Besponsa (inotuzumab ozogamicin) to treat B-cell acute lymphoblastic leukemia (ALL).

B-cell ALL is a rapidly growing cancer that occurs when the bone marrow makes too many B-cell lymphocytes, a type of white blood cell. Almost 6,000 people in the United States are likely to be diagnosed with the disease this year, and more than 1,400 are projected to die from it, according to estimates from the U.S. National Cancer Institute.

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Mavyret Approved for Hepatitis C

FRIDAY, Aug. 4, 2017 --Mavyret (glecaprevir and pibrentasvir) has been approved by the U.S. Food and Drug Administration to treat adults with certain types of chronic hepatitis C virus (HCV).

The combination drug is the first approved therapy for hepatitis C to require as few as eight weeks of treatment, the FDA said in a news release. Other therapies require treatment of 12 weeks or longer.

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New Treatment Approved for Acute Myeloid Leukemia

THURSDAY, Aug. 3, 2017 -- The combination chemotherapy drug Vyxeos (daunorubicin and cytarabine) has been approved by the U.S. Food and Drug Administration as the first treatment for certain high-risk types of acute myeloid leukemia (AML).

AML is an aggressive blood cancer that forms in the bone marrow.

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Imbruvica Approval Expanded to Include Graft Versus Host Disease

WEDNESDAY, Aug. 2, 2017 -- The U.S. Food and Drug Administration on Wednesday expanded approval for the anti-cancer drug Imbruvica (ibrutinib) to include adults with chronic graft versus host disease (cGVHD).

cGVHD is a deadly condition that affects up to 70 percent of people who receive a stem cell transplant to treat cancers of the blood or bone marrow, the FDA said in a news release. The condition occurs when the transplanted cells attack healthy cells in a patient's tissues.

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Idhifa Approved for Some With Acute Myeloid Leukemia

TUESDAY, Aug. 1, 2017 -- Idhifa (enasidenib) has been approved by the U.S. Food and Drug Administration to treat adults with a specific genetic mutation that leads to relapsed or refractory acute myeloid leukemia (AML).

The mutation in the IDH2 gene can be diagnosed with a newly approved companion diagnostic, the RealTime IDH2 Assay, the agency said in a news release Tuesday.

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MRI Approved for Young Infants in Intensive Care

THURSDAY, July 20, 2017 -- The first magnetic resonance imaging (MRI) device designed to scan the heads and brains of newborns in intensive care units has been approved by the U.S. Food and Drug Administration.

MRIs use strong magnets and radio waves to create detailed images of the body. The Embrace Neonatal MRI System is the first unit approved to provide these scans of critically ill newborns, the FDA said Thursday in a news release.

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Nerlynx Approved to Help Prevent Breast Cancer's Return

TUESDAY, July 18, 2017 -- Nerlynx (neratinib) has been approved by the U.S. Food and Drug Administration to help prevent HER2-positive breast cancer from returning.

It's the first drug designed to prevent return of HER2-positive breast cancer, a genetic form of the disease that's particularly aggressive and can spread to other parts of the body, the agency said in a news release.

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New Drug Approved for All Cancers With Genetic Marker

TUESDAY, May 23, 2017 -- Keytruda (pembrolizumab) has been approved by the U.S. Food and Drug Administration to treat any cancer that has a certain genetic biomarker, regardless of where in the body the cancer originated.

"This is an important first for the cancer community," said Dr. Richard Pazdur, acting director of the agency's Office of Hematology and Oncology Products. "Until now, the FDA has approved cancer treatments based on where in the body the cancer started, for example lung or breast cancers. We have now approved a drug based on a tumor's biomarker without regard to the tumor's original location."

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Actemra Approved for Certain Blood Vessel Inflammation

MONDAY, May 22, 2017 -- The injected drug Actemra (tocilizumab) has been approved by the U.S. Food and Drug Administration to treat adults with giant cell arteritis, an inflammation of the blood vessels (vasculitis).

In a media release Monday, the FDA said this form of vasculitis mostly involves blood vessels of the head. Traditional therapy includes large doses of anti-inflammatory drugs called corticosteroids.

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Kalydeco Approval Widened for More Types of Cystic Fibrosis

THURSDAY, May 18, 2017 -- The U.S. Food and Drug Administration says it has expanded approval for the cystic fibrosis drug Kalydeco (ivacaftor) to include 33 mutations of the disease, up from the previous 10 mutations.

In a media release, the agency said its decision was based on results of laboratory testing and previous clinical trials.

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