After our article on nivolumab (Opdivo – BMS) for treatment of metastatic melanoma and metastatic squamous non-small cell lung cancer (NSCLC) was published in the most recent issue of The Medical Letter (June 8, 2015),1 some new data became available supporting the efficacy of the drug in previously untreated melanoma and previously treated nonsquamous NSCLC.MELANOMA – In a double-blind trial, 945 patients with previously untreated, unresectable stage III or IV melanoma were randomized to receive ipilimumab, nivolumab, or combination therapy with ipilimumab and nivolumab. Progression-free...

The FDA has expanded its Emergency Use Authorizations (EUAs) for the COVID-19 vaccines manufactured by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax) to permit use of the bivalent formulations of these products (containing mRNA from the original and BA.4/5 Omicron strains of SARS-CoV-2) in children as young as 6 months. The bivalent Pfizer vaccine is authorized for use as the final dose of a 3-dose primary series in children 6 months to 4 years old. The bivalent Moderna vaccine is authorized for use as a booster dose in children 6 months to 5 years old who completed a primary...

Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy, has been approved by the FDA for treatment of adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. It is the first adenoviral vector-based gene therapy to be approved in the US for this indication. The immune checkpoint inhibitor pembrolizumab (Keytruda) was approved for the same indication in 2021.

Nogapendekin alfa inbakicept-pmln (Anktiva – ImmunityBio), a first-in-class interleukin-15 (IL15) receptor agonist, has been approved by the FDA for use with Bacillus Calmette-Guérin (BCG) for treatment of patients with BCG-unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. Such patients generally undergo bladder tumor resection, followed by intravesical BCG treatment, but treatment failure and cancer recurrence are common. The adenoviral vector-based intravesical gene therapy nadofaragene firadenovec-vncg (Adstiladrin)...

Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.

Pravastatin (Pravachol - Bristol-Myers Squibb) and simvastatin (Zocor - Merck), two new inhibitors of cholesterol synthesis similar to lovastatin (Mevacor - Merck), have been marketed in Canada and several European countries and may soon be available in the USA for treatment of high plasma cholesterol concentrations. Drugs already marketed here for this indication were recently reviewed in The Medical Letter (Volume 33, page 1, January 11, 1991).

Desloratadine (des lor at' a deen; Clarinex - Schering), an active metabolite of the H1-receptor antagonist loratadine (Claritin), has been approved by the FDA for oral treatment of allergic rhinitis and chronic urticaria in patients at least 12 years old. The patent for loratadine expires in December 2002, and generic or over-the-counter versions are expected.

Atomoxetine (Strattera - Lilly) is the first non-stimulant drug to be approved by the FDA for treatment of attention deficit hyperactivity disorder (ADHD). Unlike other drugs approved for use in ADHD, it is not a controlled substance and is approved for use in adults as well as children. Older non-stimulant drugs that have been used to treat ADHD, although not FDA-approved, include the alpha₂-agonist clonidine (Catapres, and others) and the tricyclic antidepressant desipramine (Norpramin, and others) (Medical Letter 1996; 38:109).

FluMist (MedImmune), the first live-attenuated and first intranasally administered influenza vaccine, has been approved by the FDA to prevent influenza in healthy people 5-49 years old. Given as a nasal spray, it stimulates immunity by viral replication in the upper respiratory tract. This vaccine apparently will be advertised directly to the public as a "needle-free" alternative to intramuscular influenza vaccine.

Patients with frequent, severe or disabling migraine headaches may benefit from taking a drug to prevent the attacks. Beta-blockers traditionally have been the prophylactic treatment of choice, but in recent years some antiepileptic drugs such as valproate (Depakote, and others) and topiramate (Topamax) have also been used for this indication. Valproate was approved by the FDA for such use in 1996. Now topiramate has also been approved.