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...

Intravenous immunoglobulin (IVIG) has 6 FDA approved indications and is prescribed off-label for many others. How many of these uses are justified is controversial.

Piperacillin/tazobactam (Zosyn - Lederle), an antibiotic combination product, has been approved by the US Food and Drug Administration for intravenous treatment of intra-abdominal, pelvic, skin, and skin-structure infections and for community-acquired pneumonia of moderate severity.

The FDA has approved the subcutaneously injected PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor alirocumab (Praluent – Sanofi/Regeneron) as an adjunct to diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who require additional lowering of LDL-cholesterol (LDL-C). It was not approved for general use in statin-intolerant patients. Alirocumab is the first PCSK9 inhibitor to be approved in the US. Evolocumab (Repatha – Amgen), another PCSK9 inhibitor, was...

The FDA has approved ibrexafungerp (Brexafemme – Scynexis), a first-in-class triterpenoid antifungal ("fungerp"), for oral treatment of vulvovaginal candidiasis in postmenarchal females.

In our article in issue 1564 on Plenvu for colonoscopy preparation (Med Lett Drugs Ther 2019; 61:11), the comparator drug in the DAYB trial was not Prepopik, but rather Citrafleet, a similar sodium picosulfate-based preparation that is not available in the US. Also, we said that Plenvu can be taken as a single- or split-dose regimen; we should have said that it can be taken as two doses in a single day or split over two days.

The CDC has issued new recommendations for treatment of gonococcal infection. A single 500-mg IM dose (1000 mg in patients weighing ≥150 kg) of the third-generation cephalosporin ceftriaxone is now the treatment of choice for patients with uncomplicated urogenital, rectal, or pharyngeal gonorrhea.

Ocrevus Zunovo (Genentech), a subcutaneous (SC) formulation of the anti-CD20 monoclonal antibody ocrelizumab plus human recombinant hyaluronidase-ocsq has been approved by the FDA for treatment of primary progressive and relapsing forms of multiple sclerosis (MS). Intravenous ocrelizumab (Ocrevus), which was approved for the same indications in 2017, is one of the most commonly prescribed drugs for treatment of MS. Ocrelizumab remains the only drug approved for treatment of primary progressive MS.

In our article on Slynd (Med Lett Drugs Ther 2020; 62:18), the drospirenone-only oral contraceptive, we mentioned that drospirenone has antiandrogenic activity that could improve acne and antimineralocorticoid activity that could cause hyperkalemia. We should have added that concurrent use of drospirenone with other drugs that increase potassium levels, such as the anti-androgen aldosterone receptor antagonist spironolactone (Aldactone, and generics), which is often used off-label for treatment of acne, can increase the risk of hyperkalemia.

Efalizumab (Raptiva - Genentech/XOMA), a humanized monoclonal antibody that inhibits T-cell activation, has been approved by the FDA for treatment of adults with moderate to severe chronic plaque psoriasis.