The FDA has approved lisocabtagene maraleucel (Breyanzi – BMS) for treatment of adults with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, or follicular lymphoma grade 3B who have disease refractory to first-line chemoimmunotherapy, relapsed within 12 months of or after first-line chemoimmunotherapy, are not eligible for hematopoietic stem cell transplantation due to comorbidities or age, or have relapsed or refractory disease after ≥2 lines of...

Glofitamab-gxbm (Columvi – Genentech), a bispecific CD20-directed CD3 T-cell engager, has received accelerated approval from the FDA for IV treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or large B-cell lymphoma (LBCL) arising from follicular lymphoma after ≥2 lines of systemic therapy. Accelerated approval was based on response rates and durability of response. Glofitamab is the second T-cell-engaging bispecific antibody to be approved in the US for treatment of DLBCL; epcoritamab-bysp (Epkinly), which is given...

The FDA has approved cantharidin 0.7% solution (Ycanth – Verrica) for topical treatment of molluscum contagiosum in patients ≥2 years old. Ycanth was the first drug to be approved in the US for this indication. A 10.3% gel formulation of berdazimer (Zelsuvmi), a nitric oxide-releasing agent, has also been approved by the FDA for treatment of molluscum contagiosum (in patients ≥1 year old); it will be reviewed in a future issue.

Vasodilators are widely used for treatment of congestive heart failure (CHF) that has not responded adequately to diuretics and digitalis. Vasodilator drugs redistribute blood volume in patients with heart failure, lowering pressure and reducing volume in the failing left ventricle, which leads to increased cardiac output, decreased pulmonary capillary wedge pressure, and improved exercise tolerance. Since the last Medical Letter review of this subject (Volume 26, page 115, 1984), some additional data have become available.

Octreotide acetate (Sandostatin - Sandoz), a synthetic octapeptide that mimics the actions of somatostatin, was recently approved by the US Food and Drug Administration for symptomatic treatment of patients with metastatic carcinoid or VIPomas (vasoactive intestinal peptide-secreting tumors).

An ophthalmic formulation of ciprofloxacin hydrochloride (Ciloxan - Alcon), a fluoroquinolone antibiotic, was recently marketed in the USA for treatment of bacterial keratitis and conjunctivitis. Ciprofloxacin has been used orally (Cipro) to treat a variety of serious infections (Medical Letter, 30:11, 1988) and recently was approved for intravenous administration.

Advertisements for clemastine (Tavist-1 - Sandoz), an ethanolamine oral antihistamine, have recently appeared on television and in major newspapers in the USA. Clemastine is an old drug (Medical Letter, 21:24, 1979) that has now become available without a prescription.

Many drugs, mostly imidazole derivatives, are marketed in the USA for topical treatment of vulvovaginal candidiasis (Medical Letter, 33:81, 1991). Recently, fluconazole (Diflucan - Roerig), which is the drug of choice for treatment of oropharyngeal and esophageal candidiasis (Medical Letter, 36:16, 1994), was approved by the US Food and Drug Administration for single-dose oral treatment of .

Implanted devices that monitor cardiac rhythm and can recognize and treat ventricular tachycardia or ventricular fibrillation are now widely used in the USA and other countries. Implantable cardioverter/defibrillators (ICDs) marketed here include the Ventak P and PRX (Cardiac Pacemakers, Inc., St. Paul, MN), the PCD (Medtronic, Minneapolis, MN), and the Cadence (Ventritex, Sunnyvale, CA) (JG Porterfield et al, Am J Cardiol, 72:301, 1993).

Nalmefene (Revex - Ohmeda), an i methylene analog of naltrexone (Trexan), is a long-acting opioid antagonist that has been approved by the US Food and Drug Administration for reversal of postoperative opioid drug effects, including respiratory depression, sedation and hypotension and for management of known or suspected opioid overdose in the emergency department. The only other opioid antagonists available in the USA are naloxone (Narcan), which is also injectable but has a short duration of action, and naltrexone, which has a long duration of action but is marketed only for oral...