FDA Fast Track Designation for INX-315 to Treat CCNE1-Amplified Platinum-Resistant/Refractory Ovarian Cancer
“The FDA’s decision to grant Fast Track designation for INX-315 reflects the best-in-class potential of our CDK2 inhibitor, the strength of our preclinical and early clinical data and the urgency to address significant unmet need in patients with CCNE1-amplified platinum-resistant/refractory ovarian cancer,” said Patrick Roberts, PharmD, PhD, Chief Executive Officer and Co-Founder of Incyclix Bio. “We look forward to working closely with the FDA to advance the clinical development of INX-315 to bring it to patients as soon as possible.”
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