The FDA has approved daraxonrasib (Rasonque – Revolution Medicines), an oral RAS GTPase multi-selective inhibitor, for treatment of metastatic pancreatic adenocarcinoma, regardless of RAS G12 mutation status, in adults who received at least one prior systemic therapy or are not candidates for multi-agent systemic therapy. It is the first RAS GTPase inhibitor to be approved in the US for any indication.

The FDA has approved cangrelor (Kengreal – The Medicines Company), an IV P2Y12 platelet inhibitor, as an adjunct to percutaneous coronary intervention (PCI) in patients who have not been pretreated with a P2Y12 inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.

Certolizumab pegol (Cimzia – UCB), a tumor necrosis factor (TNF) inhibitor previously approved for treatment of Crohn's disease and rheumatoid arthritis, and ustekinumab (Stelara – Janssen), a human interleukin-12 and -23 antagonist previously approved for treatment of moderate-to-severe plaque psoriasis, have now been approved by the FDA for treatment of active psoriatic arthritis.

The FDA has approved an IV formulation of the epoxide antibacterial drug fosfomycin (Contepo – Meitheal) for treatment of adults with complicated urinary tract infections (cUTIs) caused by susceptible isolates of Escherichia coli or Klebsiella pneumoniae. Oral fosfomycin has been available in the US for years for treatment of uncomplicated urinary tract infections. IV fosfomycin has been available in other countries for decades.

Aliskiren (ah LIS ker in; Tekturna - Novartis), the first direct renin inhibitor, has been approved by the FDA for treatment of hypertension. It is indicated for oral use either as monotherapy or in combination with other antihypertensive agents.

Deflazacort (Emflaza – PTC Therapeutics), an oral corticosteroid, has been approved by the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients ≥5 years old. It has been available outside the US for many years. Deflazacort is the second drug to be approved for treatment of DMD; eteplirsen (Exondys 51), an antisense oligonucleotide approved for IV administration in patients with mutations of the dystrophin gene amenable to exon 51 skipping (about 13% of DMD cases), was the first.

The severity and rapid spread of COVID-19 (caused by SARS-CoV-2) have raised questions about the use of some drugs in patients with the disease and whether currently available drugs could be effective in treating it. Definitive answers are lacking, but some recommendations can be made. For additional information on specific drugs, see our table Some Drugs Being Considered for Treatment of COVID-19.

The FDA has approved a fixed-dose combination of the integrase strand transfer inhibitor (INSTI) elvitegravir, the pharmacokinetic enhancer cobicistat, and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir disoproxil fumarate (Stribild – Gilead) for treatment of HIV-1 infection in antiretroviral treament-naïve adults. Elvitegravir is the second INSTI to be approved by the FDA for use in HIV treatment; raltegravir (Isentress) was the first.

The FDA has approved Widaplik (Azurity), a fixed-dose combination of the angiotensin receptor blocker (ARB) telmisartan, the dihydropyridine calcium channel blocker amlodipine, and the thiazide-like diuretic indapamide, for treatment of hypertension in adults. Telmisartan, amlodipine, and indapamide are also available alone and in various combinations for treatment of hypertension. Two three-drug combinations containing an ARB, amlodipine, and the thiazide diuretic hydrochlorothiazide (Exforge HCT and Tribenzor) have been available for years (see Table 1).

The FDA has approved Odefsey (Gilead), a once-daily, fixed-dose combination of the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine and the nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) emtricitabine and tenofovir alafenamide, for initial treatment of HIV-1 infection in patients with HIV-1 RNA (viral load) ≤100,000 copies/mL or to replace a stable antiretroviral regimen in patients who have been virologically suppressed (viral load <50 copies/mL) for at least six months with no history of treatment failure.