A new needle-free system (cool.click) has been approved by the FDA for subcutaneous delivery of Saizen (recombinant somatotropin - Serono). Somatotropin is used for long-term treatment of children with growth failure due to inadequate secretion of endogenous growth hormone. Children with growth hormone deficiency require injections daily or several times weekly for many years.

The FDA has approved the immune checkpoint inhibitor atezolizumab (Tecentriq – Genentech) for treatment of locally advanced or metastatic urothelial carcinoma and metastatic non-small cell lung cancer (NSCLC) that have progressed during or following platinum-based chemotherapy. Atezolizumab is the first programmed death-ligand 1 (PD-L1) blocking antibody to become available in the US. Two other immune checkpoint inhibitors, the programmed death receptor-1 (PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda), are also approved for treatment of metastatic NSCLC, and...

The FDA has approved a 0.25% ophthalmic solution of the ectoparasiticide lotilaner (Xdemvy – Tarsus) for treatment of Demodex blepharitis. Lotilaner is the first drug to be approved in the US for this indication.

The results of the recently published FOURIER trial have shown a reduction in cardiovascular events with addition of the PCSK9 inhibitor evolocumab (Repatha) to statin therapy in patients with atherosclerotic cardiovascular disease (ASCVD).

Darunavir (Prezista - Tibotec), a new protease inhibitor, has received accelerated approval from the FDA for use in combination therapy of human-immunodeficiency virus (HIV) infection in previously treated adults. It is coadministered with low-dose ritonavir (Norvir), which increases its bioavailability.

Valsartan (Diovan - Novartis), a non-peptide tetrazole, is the second angiotensin II receptor antagonist approved for oral treatment of hypertension by the US Food and Drug Administration. The first was losartan (Cozaar - Medical Letter, 37:57, 1995).

Bortezomib (PS341; Velcade Millenium), the first proteasome inhibitor, has received accelerated approval from the FDA for treatment of refractory multiple myeloma. This review includes descriptions of the mechanism of action, pharmacokinetics, adverse effects, and dosage and cost of bortezomib, outlines the results of clinical studies, and concludes with an overall assessment of the drug's effectiveness.

The oral kinase inhibitors selpercatinib (Retevmo – Lilly) and pralsetinib (Gavreto – Blueprint Medicines/Genentech) have been approved by the FDA for treatment of advanced or metastatic RET-mutant or RET fusion-positive cancers. They are the first drugs to be approved specifically for certain RET-driven cancers. Both drugs were granted accelerated approval based on overall response rates and the duration of response.

Duloxetine hydrochloride (Cymbalta - Lilly), a selective serotonin and norepinephrine reuptake inhibitor (SNRI), has been approved by the FDA for treatment of major depressive disorder in adults, and more recently for diabetic peripheral neuropathy as well. The Medical Letter will review its role in diabetic neuropathy in a future issue.

Anistreplase (Eminase - SmithKline Beecham, Upjohn), a plasminogen activator also known as APSAC, was recently approved by the US Food and Drug Administration (FDA) for intravenous (IV) thrombolytic treatment of coronary thrombosis. Three other thrombolytic agents - intracoronary urokinase (Abbokinase) and intracoronary or intravenous streptokinase (Streptase; Kabikinase) and alteplase (TPA; Activase)- were previously approved for coronary thrombolysis (Medical Letter, 29:107, 1987).