An announcement was made today by the Daiichi Sankyo that it’s TURALIO has been approved by the United States Food and Drug Administration as the first and exclusive treatment for those patients with symptomatic TGCT associated with functional limitations or stark morbidity and which cannot be otherwise treated by any surgery. TGCT is a non-malignant, rare tumor which impacts small, as well as, large joints. Debilitating symptoms can be caused by the disease and it can be locally aggressive,
The lead investigator for the pivotal phase III ENLIVEN study, The Managing Director, as well as, the Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center, William D. Tap stated that the approval by the FDA of TURALIO gives a representation of a paradigm shift in the treatment of cautiously selected TGCT patients who face major disease morbidity and for whom there is no treatment option by surgery. Now we have a novel oral option of treatment which can have a significant clinical benefit in select patients, inclusive of a reduction in the size of the tumor.
The Managing Director, Executive President, as well as, the Global Head of the Oncology Research and Development Daiichi Sankyo Inc., Antoine Yver stated that they are delighted to be a part of today’s breakthrough approval and offer a treatment which was much needed for the advancement for TGCT patients who can otherwise not be treated with surgery, and who, up till now, have had no such approved systemic treatment options. With patients at the target of whatever we do, Daiichi Sankyo believes that the safety of the patient and providing them with effective medicines is the most important responsibility of ours. As such, we are highly committed to educating healthcare providers and patients about the risks and benefits associated with TURALIO to make sure there is appropriate prescribing and monitoring.