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Medicines licensing

Olaratumab fast-tracked for approval across EU

A new cancer drug to treat certain adult patients with rare soft tissue sarcoma is being fast-tracked for conditional approval across the EU.

The European Medicines Agency (EMA) is proposing that olaratumab (Lartruvo; Eli Lilly) should be used in combination with doxorubicin in patients with advanced disease for whom surgery or radiotherapy is not suitable and who have not been previously treated with doxorubicin.

Soft tissue sarcoma occurs in tissues that support, surround or protect organs and accounts for around 2% of all cancer-related deaths. According to the EMA, between 40% and 60% of patients with this cancer will be in an advanced stage of the disease; only half live longer than five years and this prognosis has not improved over the past 40 years.

Olaratumab is a monoclonal antibody that targets platelet-derived growth factor receptor alpha (PDGFRα), which is present in high levels or is overactive in soft tissue sarcoma, causing cells to become cancerous. By attaching to PDGFRα on sarcoma cells, olaratumab blocks its activity, thereby slowing down the growth of the cancer.

The EMA’s proposal follows a recommendation from the Committee for Medicinal Products for Human Use based on the results of a phase II study that found patients given a combination of doxorubicin and olaratumab had a longer average survival of 11.8 months compared with patients taking doxorubicin alone.

The marketing authorisation is on condition that Eli Lilly provides results from an ongoing phase III study to confirm the earlier results.

The EMA’s recommendation will go to the European Commission for approval. If given the go-ahead, it is left to each individual member state to decide whether to make the product available in its national health system and to agree its price and reimbursement.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201745

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