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AstraZeneca Triumphs with Trio of Approvals from European Commission

AstraZeneca, the British-Swedish multinational pharmaceutical and biopharmaceutical company, has recently received a triumvirate of approvals from the European Commission (EC). The EC, after reviewing the recommendations from the Committee for Medicinal Products for Human Use (CHMP), has given the thumbs up for three treatments.

Triumph One: HIMALAYA Trial

The first of the triumphant trials, HIMALAYA, was a phase 3 trial that revealed a significant reduction in the risk of death for patients suffering from Hepatocellular Carcinoma (HCC). They were treated with a specific combination therapy, compared to the standard care involving a medication called sorafenib.

The median overall survival for patients treated with the combination therapy was 16.4 months, compared to 13.8 months for those given sorafenib. After three years, an estimated 31% of the patients treated with the combination remained alive, as opposed to 20% of those treated with sorafenib.

The results of the HIMALAYA trial have given a new ray of hope for HCC patients.

Triumph Two: POSEIDON Trial

The second triumph came in the form of the POSEIDON trial, which involved patients with Non-Small Cell Lung Cancer (NSCLC). The results demonstrated a 23% reduction in the risk of death for patients treated with the combination therapy along with four cycles of platinum-based chemotherapy, compared to other chemotherapy options.

Dave Fredrickson, executive vice president of the oncology business unit at AstraZeneca, described the approval as a significant step forward. He elaborated:

"Lung cancer is one of the most prevalent and deadly cancers in Europe, and the rates of liver cancer are steadily on the rise across the region. These approvals for Imfinzi and Imjudo bring critically needed, novel immunotherapy-based treatment regimens."

Triumph Three: Calquence Approval

The third triumph was the new approval for Calquence, a treatment for adult patients with Chronic Lymphocytic Leukaemia (CLL). This followed a recommendation from the CHMP and was based on the findings of the ELEVATE-PLUS trials.

The results were encouraging, showing that the capsule and tablet formulations of the drug were bioequivalent. This means that the same efficacy and safety profile could be expected when prescribed with the same dosing strength and schedule.

Paolo Ghia, director, strategic research programme on CLL, Universita Vita-Salute San Raffaele in Milan, explained that many CLL patients grapple with multiple medical conditions that require daily treatment. This includes the use of acid-reducing agents for conditions such as gastro-oesophageal reflux. He noted:

"The tablet formulation allows for co-administration with these drugs, allowing more patients with CLL to assume Calquence."

These triumphant approvals signify a momentous stride in the field of oncology. With these novel immunotherapy-based treatments, AstraZeneca continues its commitment to providing life-extending benefits to patients across Europe and around the globe.


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