January 2025

New Products

• Amivantamab (Rybrevant) is a low-fucose, fully-human IgG1-based bispecific antibody that binds to the extracellular domains of epidermal growth factor receptor (EGFR) and mesenchymal epidermal transition (MET) receptor. It disrupts EGFR and MET signalling functions through blocking ligand binding and, in exon 20 insertion mutation models, enhancing degradation of EGFR and MET. The presence of EGFR and MET on the surface of tumour cells also allows for targeting of these cells for destruction by immune effector cells, such as natural killer cells and macrophages, through antibody-dependent cellular cytotoxicity and trogocytosis mechanisms, respectively. Rybrevant has provisional approval for the treatment of patients with locally advanced or metastatic non-small cell lung cancer that has an activating EGFR exon 20 insertion mutation, whose disease has progressed on or after platinum-based chemotherapy. Rybrevant concentrate for infusion contains amivantamab 350 mg per 7 mL and is available in packs of 1 vial.
   
• SARS‑CoV‑2 JN.1 mRNA vaccine (Spikevax JN.1) is formulated in lipid particles, which enable delivery of the nucleoside-modified mRNA into host cells to allow expression of the SARS‑CoV‑2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID‑19. Spikevax JN.1 is indicated for active immunisation to prevent COVID‑19 in individuals 12 years of age and older in accordance with official recommendations. Spikevax JN.1 is contraindicated in individuals with known severe allergic reactions (e.g. anaphylaxis) to a previous dose of Spikevax (Original, Bivalent Original/Omicron (BA.1), Bivalent Original/Omicron BA.4‑5 or XBB.1.5). Spikevax JN.1 suspension for injection contains SARS-CoV-2 JN.1 mRNA 50 mcg per 0.5 mL dose and is available in packs of 10 prefilled syringes.
   
• Talazoparib (tosilate) (Talzenna) is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1 and PARP2, which play a role in DNA repair. In vitro studies with cancer cell lines that harboured defects in DNA repair genes, including breast cancer susceptibility gene (BRCA) 1 and 2, have shown that talazoparib-induced cytotoxicity may involve inhibition of PARP enzymatic activity and increased formation of PARP-DNA complexes resulting in DNA damage, decreased cell proliferation and apoptosis. Talazoparib anti-tumour activity was observed in human patient-derived xenograft breast cancer tumour models that expressed mutated or wild‑type BRCA 1 and 2, as well as in an androgen receptor (AR) positive prostate cancer cell line xenograft model. The combination of a PARP inhibitor and AR signalling inhibitor has been identified as a mechanism-based interaction that expands the functional state of sensitivity to broader inhibition of homologous recombination DNA repair mechanisms. AR signalling inhibition suppresses the expression of homologous recombination repair (HRR) genes including BRCA1, resulting in sensitivity to PARP inhibition. PARP1 activity has been shown to be required for maximal AR function and thus inhibiting PARP may reduce AR signalling and increase sensitivity to AR signalling inhibitors. Clinical resistance to AR blockade is sometimes associated with co‑deletion of retinoblastoma RB1 and BRCA2, which is in turn associated with sensitivity to PARP inhibition. Talzenna is indicated for the treatment of patients with a deleterious or suspected deleterious germline BRCA mutation according to a validated diagnostic test, who have human epidermal growth factor receptor 2‑negative, locally advanced or metastatic breast cancer and in combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer. Talzenna capsules contain talozaparib 100 mcg, 250 mcg, 350 mcg or 500 mcg and are available in packs of 30.

New Indications

• Brexpiprazole (Rexulti) is now indicated for the treatment of agitation associated with Alzheimer’s dementia, in adult patients who are unresponsive to non-pharmacological interventions.
   
• Nivolumab (rch) (Opdivo) is now indicated in combination with cisplatin and gemcitabine for the first-line treatment of patients with unresectable or metastatic urothelial carcinoma.
   
• Osimertinib (mesilate) (Tagrisso) is now indicated in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumours have EGFR exon 19 deletions or exon 21 L858R mutations.

Safety Related Changes

• Durvalumab (Imfinzi) in combination with pemetrexed and either cisplatin or carboplatin no longer has provisional approval for the first-line treatment of patients with unresectable malignant pleural mesothelioma with epithelioid histology.

This list is a summary of only some of the changes that have occurred over the last month.
Before prescribing, always refer to the full product information.