The FDA has approved ozanimod (Zeposia – Celgene), a sphingosine 1-phosphate (S1P) receptor modulator, for treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (initial neurological episode), relapsing-remitting disease, and active secondary progressive MS (SPMS). It is the third oral S1P receptor modulator to be approved in the US for treatment of relapsing forms of MS; siponimod (Mayzent) is also indicated for use in adults, and fingolimod (Gilenya) is approved for use in patients ≥10 years old.

The recommendations for treatment of varicella-zoster virus (VZV) and herpes simplex virus (HSV) infections are listed in tables 1 and 2. Vaccination against VZV was reviewed in a previous issue.

Calcipotriene ointment 0.005% (calcipotriol; Dovonex - Westwood Squibb), a synthetic vitamin D 3 analog previously available in Europe and Canada, has now been approved by the US Food and Drug Administration (FDA) for treatment of moderate plaque psoriasis, the most common form of the disease.

The US Food and Drug Administration (FDA) has approved use of recombinant human interleukin 11 (rhIL-11; oprelvekin; Neumega - Genetics Institute) to increase platelet counts and decrease the need for platelet transfusions in patients with severe thrombocytopenia caused by chemotherapy for nonmyeloid malignancies.

Miglitol, an oral alpha-glucosidase inhibitor similar to acarbase, is now available for treatment of type 2 diabetes.

The FDA has approved marketing of Plan B (Women's Capital Corporation), an emergency contraceptive "pill pack"that contains two 0.75-mg tablets of levonorgestrel.

Tegaserod maleate (Zelnorm – Novartis), a partial serotonin 5-HT4 receptor agonist that increases gastrointestinal motility, was approved by the FDA in 2002 for short-term treatment of constipation-predominant irritable bowel syndrome in women,1 and in 2004 for treatment of chronic constipation in adults ≤65 years old. Its efficacy has not been impressive statistically, but according to Medical Letter consultants some patients with slow-transit constipation have benefited from taking the drug. Diarrhea has been its main adverse effect.2The FDA now has requested that the manufacturer stop...

The FDA has approved Quartette (Teva), an extended-cycle combination oral contraceptive containing increasing doses of the estrogen ethinyl estradiol (EE) combined with the progestin levonorgestrel (LNG). The rationale is that a gradual increase in the EE dose may reduce unscheduled bleeding or spotting, a common adverse effect of extended-cycle oral contraceptives.

The FDA has approved tisagenlecleucel (Kymriah — Novartis), an individualized, genetically-modified cellular product, for treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in patients ≤25 years old. The patient's own T cells are genetically modified to express chimeric antigen receptors (CAR) and then reinfused. Kymriah is the first CAR T-cell immunotherapy to become available in the US. A CAR T-cell product for B-cell non-Hodgkin's lymphoma is expected to be approved soon.

The FDA has approved axicabtagene ciloleucel (Yescarta – Kite) for treatment of adults with relapsed or refractory CD19+ large B-cell lymphoma after ≥2 lines of systemic therapy. Yescarta is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. It is the second CAR T-cell immunotherapy to become available in the US. Tisagenlecleucel (Kymriah), a CAR T-cell product previously approved for treatment of relapsed or refractory B-cell...