The Medical Letter continues to receive inquiries about the value of edetate disodium (EDTA) chelation therapy for cardiovascular disease. The last Medical Letter article on this subject was published in 1981 (volume 23, page 51). Some authors have estimated that more than 500,000 people receive this form of treatment each year (MT Grier and DG Meyers, Ann Pharmacother, 27:1504, Dec 1993).

Cysteamine bitartrate (Cystagon - Mylan), an orphan drug, has been approved by the US Food and Drug Administration for oral treatment of nephropathic cystinosis, an autosomal recessive metabolic disorder that affects only a few hundred people in the USA (WA Gahl et al, in The Metabolic Basis of Inherited Disease, 7th ed., CR Scriver et al, eds, New York:McGraw-Hill, 1995, p 3763).

Irinotecan hydrochloride (Camptosar - Pharmacia & Upjohn; formerly CPT-11) has been approved by the US Food and Drug Administration for treatment of metastatic colorectal cancer refractory to other drugs including fluorouracil (5-FU; Adrucil and others).

Donepezil hydrochloride (Aricept - Eisai), a piperidine-based acetylcholinesterase inhibitor, is now being marketed for oral treatment of cognitive symptoms in patients with mild to moderate dementia due to Alzheimer's disease. Donepezil is the second drug approved for this indication; tacrine hydrochloride (Cognex), also an acetylcholinesterase inhibitor, has been available in the USA for four years (Medical Letter, 35:87, 1993).

Pentosan polysulfate sodium (Elmiron - Baker Norton), a semi-synthetic mucopolysaccharide structurally similar to heparin, has been approved by the US Food and Drug Administration for oral treatment of interstitial cystitis.

The FDA has approved ipilimumab (Yervoy – Bristol-Myers Squibb), a recombinant human monoclonal antibody, for treatment of unresectable or metastatic melanoma.

Ocriplasmin (Jetrea – ThromboGenics) was recently approved by the FDA as an intravitreal injection for treatment of symptomatic vitreomacular adhesion. It is the first drug to be approved in the US for this indication.

The FDA has approved the use of subcutaneous injections of deoxycholic acid (Kybella – Kythera/Allergan) to improve the appearance of moderate to severe convexity or fullness associated with submental fat (double chin) in adults. It is the first drug approved for this indication.

On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.

The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. About 13-15% of lung cancers are small-cell cancers. Most SCLCs occur in patients who are current or former smokers.