Editor’s Note: This is an updated version of an article written before the recent FDA approval of olaratumab.
On October 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Lartruvo (olaratumab) with doxorubicin for patients with soft tissue sarcoma (STS) who cannot be treated with radiation or surgery and for whom chemotherapy is the appropriate treatment.1 Olaratumab inhibits tumor growth by blocking platelet-derived growth factor (PDGF) receptors.
STS is a group of cancers with mesenchymal origins that affect connective and soft tissues. It is a rare disease, representing less than 1% of all cancers in the United States. Until the development of doxorubicin and ifosfamide in the 1970s, nonsurgical treatment was typically limited to vincristine, actinomycin-D, and cyclophosphamide (VAC), which had a varied response rate depending on the sarcoma subtype.2
Surgery is still the most common treatment of STS, as it remains the only means of curing the disease. If a tumor is removed with clear margins, no additional treatment is required. If surgery is not possible, or if the STS is metastatic or recurrent following surgery, doxorubicin and ifosfamide are often prescribed.3
In a randomized trial of olaratumab involving 133 patients with more than 25 subtypes of metastatic STS, patients who received olaratumab with doxorubicin had a median overall survival of 26.5 months, compared to 14.7 months for patients who received doxorubicin alone, and 8.2 months of progression-free survival, compared to 4.4 months. Patients who received olaratumab with doxorubicin also had 18.4 percent tumor shrinkage, compared to 7.5 percent.
“The improvement in overall survival observed with olaratumab for the treatment of patients with sarcoma represents a major new advance,” said Gary Schwartz, MD, chief of hematology and oncology at New York-Presbyterian/Columbia University Medical Center, New York, NY, said in an email to Cancer Therapy Advisor.
“Doxorubicin has been the standard of care for patients with metastatic sarcoma for decades. This is the first time that a drug, when added to doxorubicin, has been shown to result in a meaningful improvement in survival in this disease. This accelerated approval of olaratumab by the FDA provides new hope to cancer patients with sarcoma.”
The clinical evidence provided by the trial prompted the FDA to grant fast track designation, breakthrough therapy designation, and priority review to olaratumab under its accelerated approval program. Additionally, the agency granted orphan drug status to olaratumab, which provides development incentives including fee waivers and tax credits.1