FDA Grants Accelerated Approval to Soft Tissue Sarcoma Treatment

The FDA granted accelerated approval to olaratumab (Lartruvo) with doxorubicin in patients with certain types of soft tissue sarcoma (STS).

Lartruvo is a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody, designed to block PDGF receptors to help slow or stop tumor growth. The drug was approved for use in patients with STS who cannot be cured with radiation or surgery, and who have a type of STS for which an anthracycline is an appropriate treatment, according to the press release.

“For these patients, Lartruvo, added to doxorubicin, provides a new treatment option,” said Richard Pazdur, MD, director of the FDA’s Office of Hematology and Oncology Products 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.”

The approval was based on a randomized trial that enrolled 133 patients with more than 25 different subtypes of metastatic STS to examine the safety and efficacy of Lartruvo. Patients were given either Lartruvo with doxorubicin or doxorubicin alone. The trial measured overall survival (OS), progression-free survival (PFS) and overall response rate.

The results of the study showed that patients who received Lartruvo with doxorubicin had a statistically significant improvement in OS, with a median survival of 26.5 months, compared with 14.7 months for patients who received doxorubicin alone.

Median PFS in patient who received Lartruvo with doxorubicin was 8.2 months, compared with 4.4 months for patients in the doxorubicin monotherapy group. Tumor shrinkage was 18.2% for patients in the Lartruvo with doxorubicin arm and 7.5% in the doxorubicin monotherapy arm.

The most common adverse events with Lartruvo were nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. Serious adverse events include infusion-related reactions and embryo-fetal harm.

“The FDA approval of this new treatment represents an important milestone for patients diagnosed with this difficult-to-treat disease, with limited treatment options,” said Richard Gaynor, MD, senior VP, product development and medical affairs, Lilly Oncology. “This approval underscores Lilly’s commitment to providing new, valuable treatment options to people living with rare cancers.”