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Accelerated Approval for Soft Tissue Sarcoma Treatment

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Accelerated Approval for Soft Tissue Sarcoma Treatment Accelerated Approval for Soft Tissue Sarcoma Treatment he FDA granted accelerated ap- effects of treatment with olaratumab tion, breakthrough therapy designation, proval program, which allows approval proval to olaratumab (Lartruvo) are nausea, fatigue, neutropenia, mus- and priority review status because pre- of a drug to treat a serious or life- Twith doxorubicin to treat adults with culoskeletal pain, mucositis, alopecia, liminary clinical evidence indicated it threatening disease or condition based certain types of soft tissue sarcoma (STS). vomiting, diarrhea, decreased appe- may offer a substantial improvement on clinical data showing the drug has Olaratumab is approved for use with tite, abdominal pain, neuropathy, and in effectiveness in the treatment of a an effect on a surrogate endpoint that is the FDA-approved chemotherapy drug headache. serious or life-threatening disease or reasonably likely to predict clinical ben- doxorubicin for the treatment of patients The FDA granted the olara- condition. The FDA is approving the efit. Olaratumab also received orphan with STS who cannot be cured with ra- tumab application fast track designa- drug under the agency’s accelerated ap- drug designation. OT diation or surgery and who have a type of STS for which an anthracycline is an appropriate treatment. “For these patients, Lartruvo, added to doxorubicin, provides a new treat- ment option,” said 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. “This is the first new therapy approved by the FDA for the initial treat- ment of soft tissue sarcoma since doxoru- bicin’s approval more than 40 years ago.” The NCI estimates that 12,310 new cases of STS and nearly 5,000 deaths are likely to occur from the disease in 2016. The most common treatment for STS that cannot be removed by surgery is treatment with doxorubicin alone or with other drugs. STS includes a wide variety of tumors arising in the muscle, fat, blood vessels, nerves, tendons or the lining of the joints. Olaratumab is a platelet-derived growth factor (PDGF) receptor-alpha blocking antibody. When stimulated, PDGF receptors cause tumor growth. It works by blocking these receptors, which may help slow or stop tumor growth. The safety and efficacy of olaratumab were studied in a randomized clinical trial involving 133 patients with more than 25 different subtypes of metastatic STS. Patients received either olaratumab with doxorubicin or doxorubicin alone. This trial measured overall survival, progression- free survival, and overall response rate. Patients in this trial who received olaratumab with doxorubicin had a statistically significant improvement in overall survival: the median survival was 26.5 months compared to 14.7 months for patients who received doxorubi- cin alone. Patients who received olara- tumab with doxorubicin had a median progression-free survival of 8.2 months compared to 4.4 months for patients who received doxorubicin alone. Tumor shrinkage was 18.2 percent for patients who received olaratumab with doxoru- bicin and 7.5 percent for those who re- ceived doxorubicin alone. Olaratumab has serious risks in- cluding infusion-related reactions and embryo-fetal harm. Infusion-related re- actions include low blood pressure, fever, chills, and rash. The most common side 26 Oncology Times.
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