The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has been approved by the FDA for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangements. It is the first targeted therapy to be approved in the US for this indication. The drug received accelerated approval from the FDA in 2020 for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or other rearrangements.

Maribavir (Livtencity – Takeda), an oral cytomegalovirus (CMV) pUL97 kinase inhibitor, has been approved by the FDA for treatment of post-transplant CMV infection refractory to standard antiviral therapy in patients ≥12 years old who weigh at least 35 kg.

Caplacizumab-yhdp (Cablivi – Sanofi /Genzyme), a von Willebrand factor-directed antibody fragment, has been approved by the FDA for use in combination with plasma exchange and immunosuppressive therapy for treatment of immune-mediated thrombotic thrombocytopenic purpura (iTTP; formerly called acquired thrombotic thrombocytopenic purpura [aTTP]) in adults. It is the first drug to be approved in the US for this indication.

A recent article in JAMA and an interview of its senior author on 60 Minutes have heightened interest in off-label use of the oral selective serotonin reuptake inhibitor (SSRI) fluvoxamine (Luvox, and generics) to treat COVID-19.

A fixed-dose combination of orphenadrine citrate, aspirin, and caffeine (Orphengesic Forte – Galt; previously available as Norgesic Forte) has been approved as a prescription drug by the FDA for treatment of mild to moderate pain caused by acute musculoskeletal disorders. Single-ingredient generic orphenadrine citrate is available by prescription in oral and injectable formulations and has been used for years as an adjunct for treatment of acute musculoskeletal pain. Orphengesic Forte is being marketed as a non-opioid alternative for pain relief.

The FDA has approved osimertinib (Tagrisso – AstraZeneca), an oral kinase inhibitor, for adjuvant treatment of non-small cell lung cancer (NSCLC) after tumor resection in adults who have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations. Osimertinib is the first targeted therapy to be approved in the US for this indication. The drug was previously approved for first-line treatment of adults with NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations and for treatment of EGFR T790M mutation-positive NSCLC in adults whose disease progressed...

The subcutaneously injected interleukin (IL)-4 receptor alpha antagonist dupilumab (Dupixent – Sanofi/Regeneron) has been approved by the FDA for treatment of chronic spontaneous urticaria in patients ≥12 years old who remain symptomatic despite H₁-antihistamine treatment. Dupilumab was approved earlier for treatment of asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, and chronic obstructive pulmonary disease with an eosinophilic phenotype.

The FDA has approved Erzofri (Luye), an extended-release injectable formulation of the second-generation antipsychotic drug paliperidone palmitate, for treatment of schizophrenia and schizoaffective disorder in adults. It is the second once-monthly formulation of paliperidone palmitate to be approved in the US for these indications; Invega Sustenna was the first. Longer-acting injectable formulations of paliperidone palmitate are also available (see Table 1).

The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has been approved by the FDA for adjuvant treatment of adults with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative, high-risk early breast cancer who received prior neoadjuvant or adjuvant chemotherapy. The drug was previously approved for treatment of adults with deleterious or suspected deleterious gBRCAm, HER2-negative metastatic breast cancer who received chemotherapy in the neoadjuvant, adjuvant, or metastatic...

The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has now been approved by the FDA for use in combination with abiraterone (Zytiga, and others) and either prednisone or prednisolone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib was previously approved by the FDA for treatment of adults with deleterious or suspected deleterious germline or somatic homologous recombinant repair (HRR) genemutated mCRPC who progressed on prior treatment with...