AstraZeneca PLC on Wednesday said its Imfinzi and Imjudo were approved in the European Union for the treatment of advanced liver and lung cancers. Its Calquence was also approved to treat chronic lymphocytic leukaemia.
The Cambridge, England-based pharmaceutical firm said its Imfinzi and Imjudo immunotherapy combinations were approved by the European Commission based on positive results from the Himalaya Phase III trial.
Astra said the approvals authorise Imfinzi, also known as durvalumab in combination with Imjudo, whose generic name is tremelimumab, for first-line treatment of adult patients with advanced hepatocellular carcinoma. Moreover, Imfinzi combined with Imjudo and platinum-based chemotherapy were authorised for the treatment of adult patients with metastatic non-small cell lung cancer.
Dave Fredrickson, executive vice president of AstraZeneca’s Oncology business unit said: ‘Lung cancer is one of the most prevalent and deadly cancers in Europe, and rates of liver cancer are rising steadily across the region. These approvals for Imfinzi and Imjudo bring critically needed, novel immunotherapy-based treatment regimens that will potentially deliver life-extending benefits for European patients with advanced liver and non-small cell lung cancers.’
Imfinzi is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, while Imjudo is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein.
Separately, AstraZeneca said its tablet formulation of Acalabrutinib, sold under the brand name of Calquence, has been approved in the EU for the treatment of adult patients with chronic lymphocytic leukaemia.
Chronic lymphocytic leukaemia is a rare type of cancer that affects the blood and bone marrow.
The company said the approval was based on results from the Elevate-Plus trials, conducted in 116 healthy subjects.
Fredrickson added: ‘The Calquence tablet formulation underscores our commitment to understanding the needs of the chronic lymphocytic leukaemia community and providing patient-oriented treatment solutions. Today‘s approval offers physicians and patients in the EU more flexibility to determine the right treatment plan and enables more patients to potentially benefit from this medicine.’
Back in August, Calquence was approved in the US. Calquence is a selective inhibitor of Bruton’s tyrosine kinase. Calquence binds covalently to BTK, thereby inhibiting its activity. In B cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion.
Shares were down 0.7% at 11,492.00 pence each on Wednesday morning in London.
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