FDA Approval for Olaratumab for Soft Tissue Sarcoma

Zosia Chustecka


October 19, 2016

A novel drug has been granted an accelerated approval for use in soft tissue sarcoma by the US Food and Drug Administration.

"This is the first new therapy approved by the FDA for the initial treatment of soft tissue sarcoma since doxorubicin's approval more than 40 years ago," the agency noted. The recent approvals for sarcoma have been for second-line use.

The new product, olaratumab (Lartruvo, Lilly), is a platelet-derived growth factor (PDGF) receptor-α–blocking antibody.

The FDA explains that PDGF receptors, when stimulated, cause tumor growth; this new drug blocks these receptors, which may help slow or stop tumor growth.

The accelerated approval is for use of olaratumab in combination with doxorubicin for the treatment of patients with soft tissue sarcoma who cannot be cured with radiation or surgery, and for whom anthracycline chemotherapy is an appropriate treatment.

"For these patients, olaratumab added to doxorubicin provides a new treatment option," commented Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research and acting director of the FDA's Oncology Center of Excellence.

The data supporting the accelerated approval come from a randomized trial involving 133 patients with more than 25 different subtypes of metastatic soft-tissue sarcoma. This trial was published earlier this year, http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)30587-6/abstract as reported at the time by Medscape Medical News.

The combination of olaratumab with doxorubicin showed a statistically significant improvement in overall survival, with a median overall survival of 26.5 months compared with 14.7 months for doxorubicin alone. It also improved progression-free survival (median, 8.2 months for the combination vs 4.4 months for doxorubicin alone). In addition, tumor shrinkage was 18.2% for the combination vs 7.5% for doxorubicin alone.

A larger company-sponsored study is underway.

The FDA warns that olaratumab has serious risks, including infusion-related reactions and embryo-fetal harm. Infusion-related reactions include low blood pressure, fever, chills, and rash. The most common side effects are nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache.

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