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FDA grants fast track status to TRC105 for metastatic renal cell carcinoma
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The FDA granted fast track status to TRC105 for the treatment of metastatic renal cell carcinoma, according to a press release from the drug’s manufacturer.
TRC105 (Tracon) is intended for patients with metastatic renal cell carcinoma who experienced disease progression following treatment with a VEGF inhibitor in combination with standard-dose axitinib (Inlyta, Pfizer).
"We are pleased to receive fast track designation for TRC105 for the treatment of patients with advanced renal cell carcinoma," Charles P. Theuer, MD, PhD, president and CEO of Tracon, said in a press release. "Angiogenesis drives tumor growth in renal cell carcinoma and despite multiple products approved to treat the disease, resistance to treatments remains a serious challenge. We remain encouraged by data presented at [the Genitourinary Cancers Symposium] indicating the combination of TRC105 with [axitinib] was well tolerated and demonstrated signs of activity in patients who progressed on prior VEGF inhibitors, including [sunitinib] and [pazopanib (Votrient, GlaxoSmithKline)], as well as immune checkpoint inhibitor treatment."
Researchers are currently evaluating TRC105 in combination with axitinib in a phase 2b multicenter, open-label, randomized clinical trial in patients with advanced or metastatic renal cell carcinoma. Tracon expects approximately 150 patients with clear cell renal cell carcinoma to enroll in the study, the primary endpoint of which is PFS.
Researchers also are evaluating TRC105 in combination with VEGF inhibitors for the treatment of other solid tumors and age-related macular degeneration.