October FDA Update – Approval of Cancer Drug, Lartruvo

William Salage

On October 19, 2016, the US Food and Drug Administration (FDA) approved a new drug, Lartruvo (olaratumab), to treat adults with certain soft tissue sarcomas (STS). Specifically, cancers that develop in muscles, fat, tendons or other soft tissues. Lartruvo is approved alongside the already approved drug doxorubicin for the treatment of patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which an anthracycline (chemotherapy) is an appropriate treatment.

Lartruvo’s approval marks the first time the FDA has approved an initial treatment of STS in over 40 years. The National Cancer Institute estimates that 12,310 new cases of STS and nearly 5,000 deaths are likely to occur from the disease in 2016. The most common treatment for STS that cannot be removed by surgery is treatment with doxorubicin alone or with other drugs. STS includes a wide variety of tumors arising in the muscle, fat, blood vessels, nerves, tendons or the lining of the joints.

The FDA is approving Lartruvo under the agency’s accelerated approval program, which allows approval of a drug to treat a serious or life-threatening disease or condition based on clinical data showing the drug influences a surrogate endpoint that is reasonably likely to predict clinical benefit. Lartruvo also received orphan drug designation, which provides incentives such as tax credits, user fee waivers and eligibility for exclusivity to assist and encourage the development of drugs intended to treat rare diseases