Soft Tissue Sarcoma Drug Gets FDA Accelerated Approval

Eli Lilly’s Lartruvo (olaratumab) has received accelerated approval from the US Food and Drug Administration (FDA), for the treatment of select types of soft tissue sarcoma. The drug has been approved to be used in combination with the chemotherapy drug, doxorubicin, in treating patients with soft tissue sarcoma who cannot be cured with surgery, radiation or anthracycline chemotherapy.

Soft tissue sarcomas are cancers which develop in soft tissue such as muscle, fat or tendons. According to the National Cancer Institute, 12,310 cases of the cancer are diagnosed each year, with 5,000 patients likely to die of the disease in 2016.

Soft tissue sarcoma is commonly treated with doxorubicin as a monotherapy or in combination with other drugs, if the tumor cannot be removed surgically. But some patients’ tumor types have been unresponsive to conventional treatment, leaving them with few options.

“For these patients, Lartruvo, added to doxorubicin, provides a new treatment option,” said Dr. Richard Pazdur, 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. “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.”

As a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody, Lartruvo prevents these receptors from becoming stimulated, which may stop tumor growth. In a randomized clinical trial involving 133 patients with different subtypes of metastatic soft tissue sarcoma, Lartruvo was assessed for both safety and efficacy.

Patients were given Lartruvo in combination with doxorubicin, or doxorubicin as a monotherapy. The median survival for patients in the Lartruvo treatment group was 26.5 months, compared to 14.7 months in the doxorubicin arm.

In addition, progression-free survival for Lartruvo patients was nearly doubled, to 4.2 months, compared to 4.4 months for patients taking doxorubicin alone. Finally, patients on the Lartruvo-doxorubicin combo saw significant tumor shrinkage of 18.2 percent, compared to 7.5 percent for doxorubicin patients.

In addition to receiving accelerated approval, the FDA granted Eli Lilly fast track designation, breakthrough therapy, priority review status and orphan drug designation for Lartruvo. Eli Lilly is currently conducting a larger clinical trial to assess the drug’s efficacy across more subtypes of soft tissue carcinoma.