News from the FDA/CDC

FDA grants accelerated approval to olaratumab for soft tissue sarcoma


The Food and Drug Administration has granted accelerated approval to olaratumab with doxorubicin for the treatment of adult patients with certain types of soft tissue sarcoma.

“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,” Richard Pazdur, MD, director of the office of hematology and oncology products in the FDA Center for Drug Evaluation and Research and acting director of the FDA Oncology Center of Excellence, said in a statement.

Olaratumab, a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody, is approved for use with doxorubicin for the treatment of patients with soft tissue sarcoma who cannot be cured with radiation or surgery and who have a type of soft tissue sarcoma for which an anthracycline is an appropriate treatment, according to the FDA announcement.

Approval was based on a statistically significant improvement in survival in a randomized trial involving 133 patients with more than 25 different subtypes of metastatic soft tissue sarcoma. Patients received olaratumab (Lartruvo) with doxorubicin or doxorubicin alone. Median survival was 26.5 months for patients who received both drugs, compared with 14.7 months for patients who received doxorubicin alone. Median progression-free survival was 8.2 months for patients who received both drugs and 4.4 months for patients who received doxorubicin alone.

The most common adverse reactions from olaratumab were nausea, fatigue, neutropenia, musculoskeletal pain, mucositis, alopecia, vomiting, diarrhea, decreased appetite, abdominal pain, neuropathy, and headache. There are serious risks of infusion-related reactions and embryo-fetal harm, the FDA warned.

Olaratumab was approved under the FDA’s accelerated approval program after receiving fast track designation, breakthrough therapy designation, and a priority review status. The drug also received an orphan drug designation. Drug maker Eli Lilly is currently conducting a larger study of olaratumab across multiple subtypes of soft tissue sarcoma.

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