Novartis halts clinical trials following patient deaths
Keystone-SDA
At the end of August, Novartis halted several clinical trials of experimental cell therapies for autoimmune diseases in the fields of immunology and neuroscience, following the deaths of three patients.
The Basel-based pharmaceutical giant confirmed the news to the AWP news agency, which had initially been reported by the US newspaper The Wall Street Journal (WSJ), stating that the decision to suspend the programmes in question “follows the reporting of three cases of immune effector cell-associated haemophagocytic syndromes, the complications of which proved fatal”.
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The experimental treatment, known as rapcabtagene autoleucel (or rap-cel), is based on a cell therapy known as CAR-T, which genetically modifies a patient’s white blood cells to induce them to destroy defective cells. Death due to an immune reaction is a known risk associated with this type of therapeutic approach, and the WSJ noted that the US competitor Bristol-Myers Squibb had previously suspended similar trials as a precautionary measure.
Novartis was, however, keen to emphasise that the rap-cel programme in oncology is in no way affected by the suspension. The company is now carefully evaluating the data that has emerged to determine the next steps.
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Translated from Italian, reviewed by an English Department journalist.
