The US Food and Drug Administra­tion (FDA) approved a new indication for paclitaxel protein-bound particles for injectable suspension, albumin-bound (Abraxane; Celgene) for the treatment of patients with metastatic pancreatic cancer. Removal of the pancreas by surgery is the only curative option in pancreatic cancer, but this option is no longer useful by the time this type of cancer is diagnosed, when the cancer has metastasized.

On April 29, 2016, the FDA approved oxycodone (Xtampza ER) extended-release (ER) capsules, an opioid agonist, for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
The US Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases.

The FDA accelerated the approval of the oral mTOR kinase inhibitor everolimus (Afinitor; Novartis) for the treatment of kidney tumors (ie, renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC). This is the first drug approved specifically by the FDA for this patient population.

TSC is a rare genetic disease causing noncancerous tumors in the kidney, brain, and other organs. There are approximately 40,000 patients with TSC in the United States, of whom 70% or 80% develop kidney problems.

The FDA approved the mTOR in­hib­itor everolimus (Afinitor; Novartis) for use in combination with exemestane (Aromasin) for the treatment of postmenopausal women with ad­vanced hormone-receptor–positive, HER2-negative breast cancer, who had disease recurrence or progression after receiving letrozole (Femara) or anastrozole (Arimidex). The approval was based on a study of 724 postmeno­pausal women with estrogen-receptor–positive, HER2-negative advanced breast cancer that had spread despite previous therapy with letrozole or anastrozole.

The US Food and Drug Administration approved the use of apremilast (Otezla), a phosphodiesterase-4 inhibitor, on March 21, 2014, for the treatment of adults with active psoriatic arthritis.

The FDA approved asparaginase Erwinia chrysanthemi (Erwinaze, Eusa Pharma) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to Escherichia coli–associated asparaginase and pegaspargase chemotherapy drugs used for the treatment of ALL.

The FDA approved belinostat (Beleodaq; Spectrum Pharmaceuticals) for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and fast-growing type of non-Hodgkin lymphoma (NHL).
On February 9, 2016, Celltrion's infliximab biosimilar CT-P13 was recommended for approval by a vote of 21 to 3 by the US Food and Drug Administration's (FDA) Arthritis Advisory Committee.
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