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European Commission grants AstraZeneca three new approvals

The indications are for adults with liver and lung cancers, and chronic lymphocytic leukaemia

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The European Commission (EC) has granted AstraZeneca three new drug approvals, with the company’s Imfinzi/Imjudo immunotherapy combinations authorised for advanced liver and lung cancers, and a tablet formulation of Calquence for chronic lymphocytic leukaemia (CLL).

The Imfinzi/ Imjudo approvals authorise the combination to be used for the first line treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC), with the addition of platinum-based chemotherapy for adults with metastatic non-small cell lung cancer (NSCLC).

The EC’s decision, which follows a recommendation by the Committee for Medicinal Products for Human Use (CHMP) in December, was supported by positive results from the HIMALAYA and POSEIDON phase 3 trials.

In HIMALAYA, the combination was associated with a significant reduction in the risk of death in HCC patients, at 22% versus standard of care sorafenib.

Median overall survival was 16.4 months versus 13.8 for sorafenib, and an estimated 31% of patients treated with the combination were still alive after three years, compared to 20% of sorafenib-treated patients.

Results from POSEIDON showed a 23% reduction in risk of death of NSCLC patients treated with the combination plus four cycles of platinum-based chemotherapy, versus a range of chemotherapy options.

Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, 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 NSCLCs.”

The new approval for Calquence for adult patients with CLL, which also follows a recommendation from the CHMP, was based on the ELEVATE-PLUS trials.

Results showed the capsule and tablet formulations of the drug were bioequivalent, indicating the same efficacy and safety profile can be expected when prescribed with the same dosing strength and schedule.

Paolo Ghia, director, strategic research programme on CLL, Università Vita-Salute San Raffaele in Milan, explained that many CLL patients face multiple medical conditions that require daily treatment, including the use of acid-reducing agents for conditions such as gastro-oesophageal reflux, saying: “The tablet formulation allows for co-administration with these drugs, allowing more patients with CLL to assume Calquence.”

Article by
Emily Kimber

23rd February 2023

From: Regulatory



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