Anagrelide (an ag' gre lide) hydrochloride (Agrylin - Roberts), a quinazolin derivative, has been approved by the FDA for oral treatment of essential thrombocythemia. Patients with this uncommon myeloproliferative disorder have an increased number of circulating platelets and are at risk for both thrombosis and hemorrhage.

Ceritinib (Zykadia – Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). It is the second tyrosine kinase inhibitor to be approved for ALK-positive metastatic NSCLC; crizotinib was the first. Translocations of the ALK gene are found in about 5% of lung cancers; they occur predominantly in nonsmokers with adenocarcinoma.

The FDA has approved the use of a transcutaneous electrical nerve stimulation device (Cefaly – Cefaly Technology) for prevention of episodic migraine in patients ≥18 years old. The first device to be approved in the US for migraine prevention, it is available in Canada and Europe for treatment and prevention of migraines. A transcranial magnetic stimulation device (SpringTMS - eNeura Therapeutics) recently approved by the FDA for treatment of migraine preceded by aura will be reviewed in a future issue.

The FDA has licensed the adjuvanted, recombinant varicella zoster virus (VZV) vaccine Shingrix (GSK) for prevention of herpes zoster (shingles) in adults of any age who are or will be at elevated risk because of disease- or therapy-induced immunodeficiency or immunosuppression. Shingrix has been licensed for herpes zoster prevention in adults ≥50 years old since 2017.1 It is the only VZV vaccine currently available in the US; Zostavax, a live-attenuated VZV vaccine, was withdrawn from the market in 2020.

Retifanlimab-dlwr (Zynyz – Incyte), a programmed death receptor-1 (PD-1) blocking antibody, has received accelerated approval from the FDA for treatment of metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) in adults. Accelerated approval of the drug was based on the response rate and duration of response. Retifanlimab is the third drug to be approved in the US for treatment of MCC; pembrolizumab (Keytruda), a PD-1 blocking antibody, is approved for the same indication as retifanlimab in patients ≥12 years old and avelumab (Bavencio), a programmed death...

View the Comparison Chart: Some Drugs for Irritable Bowel Syndrome with Constipation (IBS-C)

Since the last Medical Letter article on surgical correction of refractive errors (Volume 41, page 122, 1999), some new techniques have been tried and new results have been reported.

A once-daily oral formulation of mesalamine (Lialda - Shire) was recently approved by the FDA for induction of remission in patients with mild to moderate ulcerative colitis.

Treatment options for snoring and obstructive sleep apnea (OSA) now include, in addition to lifestyle remedies such as weight loss and avoidance of alcohol in the evening, mechanical devices, injection of botulinum toxin into the soft palate and a variety of ENT surgical outpatient procedures. Palatal implants (Pillar procedure - Restore Medical Inc) have been approved by the FDA for treatment of snoring and OSA.

Atogepant (Qulipta – Abbvie), an oral small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist ("gepant"), has been approved by the FDA for prevention of episodic migraine in adults. It is the second oral CGRP receptor antagonist to be approved in the US for this indication; the first was rimegepant (Nurtec ODT), which is also approved for acute treatment of migraine. Parenteral CGRP monoclonal antibodies are approved for prevention of migraine (see Table 3).