The FDA has approved ofatumumab (Arzerra – GlaxoSmithKline), a human anti-CD20 monoclonal antibody, for treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine (Fludara, and others) and alemtuzumab (Campath). It is the second anti-CD20 antibody approved for treatment of CLL; rituximab (Rituxan), a chimeric murine/human antibody, was the first.

The FDA has approved the interleukin (IL)-6 inhibitor sarilumab (Kevzara – Sanofi/Regeneron) for treatment of polymyalgia rheumatica (PMR) in adults who had an inadequate response to corticosteroids or cannot tolerate a corticosteroid taper. Sarilumab is the first biologic drug to be approved for treatment of PMR; it was previously approved for treatment of rheumatoid arthritis.

The FDA has granted accelerated approval to copanlisib (Aliqopa – Bayer), an intravenously administered phosphatidylinositol 3-kinase (PI3K) inhibitor, for treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Follicular lymphoma is a common subtype of non-Hodgkin's lymphoma. Copanlisib is the second PI3K inhibitor to be approved for this indication; idelalisib (Zydelig), which is administered orally twice daily, was the first.

The FDA has approved ibrutinib (eye broo' ti nib; Imbruvica – Janssen/Pharmacyclics), an oral kinase inhibitor, for second-line treatment of chronic lymphocytic leukemia (CLL). It is the first kinase inhibitor to be approved for CLL. Ibrutinib was approved earlier for second-line treatment of mantle cell lymphoma, a rare form of B-cell non-Hodgkins lymphoma.

Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.

Caplacizumab-yhdp (Cablivi – Sanofi /Genzyme), a von Willebrand factor-directed antibody fragment, has been approved by the FDA for use in combination with plasma exchange and immunosuppressive therapy for treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP; formerly called acquired thrombotic thrombocytopenic purpura [aTTP]) in adults. It is the first drug to be approved in the US for this indication.

Most patients with multiple sclerosis (MS) present with the relapsing-remitting form of the disease. Pharmacologic treatment usually includes a disease-modifying drug, corticosteroids for acute exacerbations, and other drugs for managing symptoms such as fatigue, depression, and pain. Early use of disease-modifying therapy has improved clinical outcomes.

The FDA has approved the recombinant chimeric anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV 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). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC ofatumumab (Kesimpta), are also FDA-approved for these indications.

Bexxar, a combination of the monoclonal antibody tositumomab and radiolabeled Iodine-131 tositumomab (Corixa Corp/GlaxoSmithKline) has been approved by the FDA for a single treatment of relapsed follicular non-Hodgkin's lymphoma (NHL) in patients who are refractory to rituximab (Rituxan - Medical Letter 1998; 40:65). It is the second radioimmunoconjugate to be approved for refractory NHL; yttrium-90 linked to ibritumomab tiuxetan (Zevalin) was approved in 2002. Tositumomab, like ibritumomab, is a monoclonal antibody of mouse origin that binds to the CD20 antigen present on the surface of >90%...

The FDA has approved the use of dalfampridine (4-aminopyridine; Ampyra – Acorda), a potassium channel blocker, to improve walking speed in patients with multiple sclerosis (MS). Walking speed is considered a reliable clinical measure of impairment in patients with MS.