Cerulean’s CRLX101 Receives Orphan Drug Status for Ovarian Cancer

June 1, 2015

The FDA has granted Cerulean Pharma’s investigational nanoparticle drug conjugate CRLX101 orphan status for the treatment of relapsed ovarian cancer, guaranteeing the drugmaker seven years added exclusivity if the product is approved.

The designation also comes with tax credits, federal grants and a waiver of PDUFA filing fees.

Cerulean currently is testing CRLX101 alongside Genentech’s Avastin (bevacizumab) in a Phase II trial. A Phase Ib trial in combination with paclitaxel chemotherapy will begin enrolling patients later this year, the company said last week.

CRLX101 uses a nanoparticle to get inside tumor cells and release a cytotoxic drug called camptothecin, which inhibits mechanisms that spur cancer cells.

CRLX101 also has fast track designation alongside Avastin for treating metastatic kidney cancer. A similar product that releases docetaxel chemotherapy inside tumor cells, CRLX301, is in Phase I, Cerulean says. — Lena Freund