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Daiichi Sankyo bags Turalio FDA approval for tenosynovial giant cell tumor

Turalio FDA approval : Daiichi Sankyo has secured approval for its CSF1R inhibitor Turalio (pexidartinib) from the US Food and Drug Administration (FDA) for the treatment of tenosynovial giant cell tumor (TGCT).

The FDA approval of Turalio is for the treatment of adult patients having symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations that is not responsive to surgery.

Tenosynovial giant cell tumor, also called pigmented villonodular synovitis (PVNS),  is a rare, non-malignant tumor affecting small and large joints, which can result in debilitating symptoms with the capability of being locally aggressive.

Turalio FDA approval

Daiichi Sankyo secures Turalio FDA approval for tenosynovial giant cell tumor. Photo courtesy of Daiichi Sankyo Company, Limited.

Basis for Turalio FDA approval

Turalio FDA approval has been driven by the findings of a phase 3 clinical trial called ENLIVEN, which was the first placebo-controlled study of a systemic therapy in tenosynovial giant cell tumor.

As per the ENLIVEN clinical trial results, the primary endpoint of tumor response rate by Response Evaluation Criteria in Solid Tumors (RECIST) was 38% in patients treated with Turalio and 0% for the placebo arm at Week 25.

Additionally, ENLIVEN clinical trial results revealed that the overall response rate by tumor volume score (TVS) was 56% in the Turalio patient arm and 0% in patients in the placebo arm at Week 25.

Also, the analysis of mean variation from baseline in the range of motion at Week 25 showed a statistically significant improvement in the Turalio patient arm compared to the placebo arm.

Commenting on Turalio FDA approval, William D. Tap – Chief of the Sarcoma Medical Oncology Service at Memorial Sloan Kettering Cancer Center, New York, and phase 3 ENLIVEN study lead investigator, said: “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.

“We now have a new oral treatment option that can have a meaningful clinical benefit in select patients, including a reduction in tumor size.”

Turalio is an oral small molecule that blocks CSF1R, which expands to colony stimulating factor-1 receptor. CSF1R is a primary growth driver of abnormal cells in the synovium that lead to tenosynovial giant cell tumor. Turalio, which also inhibits KIT and FLT3-ITD, was discovered by Plexxikon, the small molecule structure-guided research and development center of Daiichi Sankyo.

Antoine Yver – Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo, commenting on Turalio FDA approval, said: “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.

“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.”

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