Inavolisib: First Approval.

Inavolisib (Itovebi) is an orally administered, phosphatidylinositol-3-kinase alpha (PI3Kα) inhibitor being developed by Genentech, a member of the Roche group, for the treatment of solid tumours. On 10 October 2024, inavolisib received its first approval in the USA in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. In the EU and other countries worldwide, regulatory review of inavolisib is currently underway.

Bempedoic Acid: A Review in Cardiovascular Risk Reduction in Statin-Intolerant Patients.

Oral bempedoic acid (NEXLETOL in the USA; Nilemdo in the EU) and the fixed dose combination (FDC) of bempedoic acid/ezetimibe (NEXLIZET in the USA; Nustendi in the EU) are approved to reduce cardiovascular (CV) risk in statin-intolerant patients who are at high risk for, or have, CV disease. A first-in-class therapy, bempedoic acid inhibits the adenosine triphosphate-citrate lyase enzyme in the cholesterol biosynthesis pathway. In the multinational phase III CLEAR Outcomes trial in statin-intolerant patients, once-daily bempedoic acid 180 mg significantly reduced the risk of the primary endpoint (a four-component major adverse CV event composite of CV death, nonfatal myocardial infarction, nonfatal stroke, or coronary revascularization) compared with placebo.

Liposomal Irinotecan: A Review as First-Line Therapy in Metastatic Pancreatic Adenocarcinoma.

Liposomal irinotecan (Onivyde), also known as liposomal pegylated irinotecan, has been developed with the intent of maximising anti-tumour efficacy and minimising drug-related toxicities compared with conventional formulations of this topoisomerase 1 inhibitor. In combination with fluorouracil, leucovorin and oxaliplatin (NALIRIFOX), liposomal irinotecan is approved in the USA and the EU for first-line therapy of eligible patients with metastatic pancreatic adenocarcinoma. In a phase III clinical trial, NALIRIFOX significantly improved overall survival (OS) and progression free survival (PFS) compared with gemcitabine plus nanoparticle albumin bound paclitaxel (nab-paclitaxel) as first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (mPDAC).

Xeligekimab: First Approval.

Xeligekimab (Jinlixi) is a recombinant human interleukin (IL)-17A-neutralizing immunoglobulin (Ig)G4 monoclonal antibody being developed by Genrix (Shanghai) Biopharmaceutical for the treatment of plaque psoriasis, axial spondyloarthritis and lupus nephritis. Xeligekimab binds to IL-17A and blocks its interaction with the IL-17A receptor, thereby inhibiting the release of C-X-C motif chemokine ligand 1 and IL-6. On 27 August 2024, xeligekimab received approval in China for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.