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.

Camizestrant (Etcamah – AstraZeneca), an oral estrogen receptor antagonist, has received accelerated approval from the FDA for use in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer in adults who have ESR1 mutations that were detected in circulating tumor DNA (ctDNA) during treatment with an aromatase inhibitor and a CDK 4/6 inhibitor.

View the Table: Safety of Drugs for IBD in Pregnancy

The FDA has approved Seglentis (Esteve/Kowa), an oral combination of tramadol hydrochloride, a weak opioid agonist and weak serotonin and norepinephrine reuptake inhibitor (SNRI), and celecoxib, a COX-2 selective nonsteroidal anti-inflammatory drug (NSAID), for use in adults with acute pain that is severe enough to require an opioid and for which alternative treatment options are inadequate.

View the Comparison Table: Some Oral Anticoagulants for VTE

View the Comparison Table: Some Drugs for Migraine Prevention

Exagamglogene autotemcel (Casgevy – Vertex), a cell-based gene therapy recently approved for treatment of sickle cell disease1, has now been approved by the FDA for treatment of patients ≥12 years old with transfusion-dependent beta thalassemia. Casgevy is the first gene therapy that uses CRISPR/Cas9 gene-editing technology to be approved in the US for any disorder. Betibeglogene autotemcel (Zynteglo), an autologous lentiviral vector cell-based gene therapy, was approved in the US in 2022 for treatment of transfusion-dependent beta thalassemia.

Inavolisib (Itovebi – Genentech), an oral kinase inhibitor, has been approved by the FDA for use in combination with palbociclib and fulvestrant for treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This is the first approval for Itovebi; palbociclib and fulvestrant have been available for years for treatment of HR-positive, HER2-negative breast cancer.

View Table 3: Some Drug Interactions with DAAs for HCV Infection