
EMA Grants Conditional Approval to Lartruvo
The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.
The European Medicines Agency
Conditional approval is recommended when additional data may be needed but the health benefit of the treatment outweighs the risk. The agency’s Committee for Medicinal Products for Human Use (CHMP) reviewed Lartruvo under EMA’s accelerated assessment program, which facilitates early access to treatments of unmet medical needs. The recommendation was based on the results of a Phase II study that showed “significant improvement in the time patients survived with a combination of doxorubicin plus Lartruvo compared to doxorubicin alone (a median gain of 11.8 months).” Results from an ongoing Phase III study must be provided as part of the conditional marketing authorization.
"Patients with advanced soft tissue sarcoma have been seeking new treatment options that can potentially extend lives, so they can have more time with their families and loved ones," said Richard Gaynor, MD, senior vice-president of product development and medical affairs for Lilly Oncology, in a
Lartruvo, a monoclonal antibody, is a protein that recognizes and attaches to the protein platelet-derived growth factor receptor alpha (PDGFRα). In soft tissue sarcoma, PDGFRα is present in high levels or is overactive, causing cells to become cancerous. Lartruvo attaches to PDGFRα on sarcoma cells and blocks its activity, thereby slowing down the growth of the cancer.
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