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.

The investigational monoclonal antibody bebtelovimab (LY-CoV1404 – Lilly) has been granted an FDA Emergency Use Authorization (EUA) for IV treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, including hospitalization and death, and for whom alternative treatment options are unavailable or inappropriate. Bebtelovimab is active against the Omicron variant of SARS-CoV-2; sotrovimab (VIR-7831) is the only other monoclonal antibody currently available for treatment of COVID-19 that is active...

The FDA has approved the interleukin (IL)-23 antagonist mirikizumab-mrkz (Omvoh – Lilly) for treatment of moderately to severely active ulcerative colitis (UC) in adults. Mirikizumab is the first selective IL-23 antagonist to be approved for this indication. Ustekinumab (Stelara), an IL-12/23 antagonist, was approved for treatment of UC in 2019. The IL-23 antagonist risankizumab (Skyrizi) is approved for treatment of Crohn's disease.

The injectable interleukin (IL)-23 antagonist risankizumab-rzza (Skyrizi – Abbvie), previously approved by the FDA for treatment of Crohn's disease (CD), has now been approved for treatment of moderately to severely active ulcerative colitis (UC) in adults. Risankizumab is the first IL-23 antagonist to be approved for treatment of both CD and UC. It is also approved for treatment of plaque psoriasis and psoriatic arthritis.

Age-related macular degeneration (AMD) has two major forms: dry or non-neovascular (~90% of patients) and wet or neovascular (~10% of patients).

Remdesivir (Veklury – Gilead), an investigational antiviral drug administered by IV infusion, is now available through an FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in all hospitalized patients. An earlier EUA limited use of the drug to patients hospitalized with severe disease.

The interleukin-6 (IL-6) receptor antagonist tocilizumab (Actemra – Genentech) has been approved by the FDA for IV treatment of COVID-19 in hospitalized adults who are receiving a systemic corticosteroid and require supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Tocilizumab was previously available for this indication under an Emergency Use Authorization (EUA); it remains available under an EUA for treatment of children 2-17 years old who are hospitalized with COVID-19 and require oxygen support.

The immune checkpoint inhibitor dostarlimab-gxly (Jemperli – GSK) has been approved by the FDA for use in combination with carboplatin and paclitaxel for treatment of adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. Dostarlimab was recently granted regular approval for treatment of adults with dMMR recurrent or advanced endometrial cancer that progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.

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...

Cosibelimab (Unloxcyt – Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, has been approved by the FDA for treatment of locally advanced or metastatic cutaneous squamous cell carcinoma in adults who are not candidates for curative surgery or radiation. It is the first PD-L1 inhibitor to be approved in the US for this indication. The PD-1 inhibitors pembrolizumab (Keytruda) and cemiplimab (Libtayo) are also approved for treatment of cutaneous squamous cell carcinoma.