EMA Grants Conditional Approval to Lartruvo

September 16, 2016
Pharmaceutical Technology Editors

The new treatment for soft tissue sarcoma has been recommended for conditional marketing authorization in the EU.

The European Medicines Agency announced on Sept. 16, 2016 that the agency was recommending conditional marketing authorization for Lartruvo (olaratumab) in adults. The drug is used in combination with doxorubicin (a chemotherapy medicine) to treat advanced soft tissue sarcoma when surgery or radiotherapy is not suitable or when a patient was previously treated with doxorubicin. Lartruvo previously received orphan designation from EMA’s Committee for Orphan Medicinal Products (COMP) in 2015.

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 press release. "Advanced soft tissue sarcoma is a rare disease that is difficult to treat, and this milestone brings us one step closer to providing physicians in Europe with a new option that they can offer to their patients."

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.

Source: EMA