September 2020

New Products

• Acalabrutinib (Calquence) is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK). BTK is a signalling molecule of the B‑cell antigen receptor (BCR) and cytokine receptor pathways. In B‑cells, BTK signalling results in activation of pathways necessary for B‑cell proliferation, trafficking, chemotaxis, and adhesion. Acalabrutinib and its active metabolite, ACP‑5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. In nonclinical studies, acalabrutinib inhibited BTK‑mediated activation of downstream signalling proteins CD86 and CD69 and inhibited malignant B‑cell proliferation and tumour growth in mouse xenograft models. Calquence is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. This indication is approved via the provisional approval pathway, based on overall response rate. It is also indicated for the treatment of chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). Calquence capsules contain acalabrutinib 100 mg and are available in a pack size of 56.
   
• Lorlatinib (Lorviqua) is an adenosine triphosphate (ATP)‑competitive, brain‑penetrant, small molecule inhibitor of anaplastic lymphoma kinase (ALK) and ROS1 tyrosine kinases that addresses mechanisms of resistance following previous treatment with ALK inhibitor therapy. In nonclinical studies, lorlatinib inhibited catalytic activities of non‑mutated ALK and a broad range of clinically relevant ALK mutant kinases in recombinant enzyme and cell‑based assays. Lorviqua has provisional approval for the treatment of patients with ALK‑positive advanced non‑small cell lung cancer (NSCLC) whose disease has progressed on: crizotinib and at least one other ALK inhibitor; or alectinib as the first ALK inhibitor therapy; or ceritinib as the first ALK inhibitor therapy. Lorviqua is contraindicated with the concomitant use of strong CYP3A inducers due to the potential for serious hepatotoxicity. Lorviqua tablets contain lorlatinib 25 mg (available in packs of 90) and 100 mg (available in packs of 30).
   
• Tafenoquine (succinate) (Kozenis), an 8‑aminoquinoline, eradicates Plasmodium vivax (P. vivax) liver hypnozoites, preventing the relapse of malaria. The molecular target of tafenoquine is not known. Tafenoquine is indicated for the radical cure (prevention of relapse) of P. vivax malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for the acute P. vivax infection. Kozenis is contraindicated with hypersensitivity to other 8‑aminoquinolines; G‑6‑PD deficiency or unknown G‑6‑PD status due to the risk of haemolytic anaemia; pregnancy; breastfeeding an infant who is G‑6‑PD deficient or if the G‑6‑PD status of the infant is unknown. Kozenis tablets contain tafenoquine 150 mg and are available in a pack size of 2.

New Indications

• Clostridium botulinum type A toxin - haemagglutinin complex (Dysport) is now indicated for the symptomatic treatment of focal spasticity of upper limbs in children aged 2 years and older.
   
• Dulaglutide (rch) (Trulicity) is now indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or multiple cardiovascular risk factors.
   
• Insulin glargine (Toujeo) is now indicated for the treatment of diabetes mellitus in patients aged 6 years and older.
   
• Ipilimumab (rch) (Yervoy), in combination with nivolumab and 2 cycles of platinum‑doublet chemotherapy, is now indicated for the first‑line treatment of metastatic or recurrent NSCLC with no EGFR or ALK genomic tumour aberrations.
   
• Nivolumab (Opdivo), in combination with ipilimumab and 2 cycles of platinumd‑oublet chemotherapy, is now indicated for the first‑line treatment of metastatic or recurrent NSCLC with no EGFR or ALK genomic tumour aberrations.
   
• Pertussis vaccine - acellular and diphtheria and tetanus toxoids (adsorbed) combined with inactivated poliovirus type 1, 2 and 3 (Vero cell) (Adacel Polio) may be administered during pregnancy for the prevention of pertussis in young infants via transplacental antibody transfer from the pregnant woman to the foetus.