Daiichi Sankyo gets FDA nod for Turalio
Daiichi Sankyo has received the Food and Drug Administration’s clearance for Turalio (pexidartinib) as the first and only treatment for adult patients with symptomatic tenosynovial giant cell tumor, or TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
TGCT is a rare, non-malignant tumor that affects small and large joints. The disease can cause debilitating symptoms and can be locally aggressive.
"The FDA approval of Turalio represents a paradigm shift in the treatment of carefully selected TGCT patients who face significant disease morbidity and for whom surgery is not an option," said William Tap, chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center, New York, and lead investigator for the pivotal phase 3 ENLIVEN study. "We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size."
"We are proud to be a part of today's landmark approval and offer a much-needed treatment advancement for TGCT patients whose disease is not amenable to improvement with surgery, and who, until now, have had no approved systemic treatment options," said Antoine Yver, Daiichi Sankyo executive vice president and global head, oncology research and development. "With patients at the center of everything we do, Daiichi Sankyo believes patient safety and providing effective medicines are our most important responsibilities. As such, we are committed to educating patients and the healthcare providers who care for them about the benefits and risks associated with Turalio to ensure appropriate prescribing and monitoring."
TGCT is a rare, non-malignant tumor that affects small and large joints. The disease can cause debilitating symptoms and can be locally aggressive.
"The FDA approval of Turalio represents a paradigm shift in the treatment of carefully selected TGCT patients who face significant disease morbidity and for whom surgery is not an option," said William Tap, chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center, New York, and lead investigator for the pivotal phase 3 ENLIVEN study. "We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size."
"We are proud to be a part of today's landmark approval and offer a much-needed treatment advancement for TGCT patients whose disease is not amenable to improvement with surgery, and who, until now, have had no approved systemic treatment options," said Antoine Yver, Daiichi Sankyo executive vice president and global head, oncology research and development. "With patients at the center of everything we do, Daiichi Sankyo believes patient safety and providing effective medicines are our most important responsibilities. As such, we are committed to educating patients and the healthcare providers who care for them about the benefits and risks associated with Turalio to ensure appropriate prescribing and monitoring."