FDA News

FDA grants fast track status to CRLX101 for mRCC

The FDA granted fast track status to CRLX101 in combination with bevacizumab for the treatment of patients with metastatic renal cell carcinoma, according to a press release from the drug’s manufacturer.

The fast track designation for CRLX101 (Cerulean) is intended for patients whose disease progressed through two or three prior lines of therapy.

CRLX101 — a dynamically tumor-targeted nanoparticle-drug conjugate — is designed to concentrate in tumors and slowly release camptothecin, its anti-cancer payload, inside tumor cells.

CRLX101 has demonstrated activity in four types of tumors alone and in combination with other cancer therapies.

The combination of CRLX101 and bevacizumab (Avastin, Genentech) is currently being evaluated in a randomized phase 2 trial in patients with relapsed renal cell carcinoma.

“The Fast Track designation recognizes the serious unmet medical need of patients with metastatic renal cell carcinoma and the potential of CRLX101 to address this disease,” Christopher D. T. Guiffre, JD, MBA, president and chief executive officer of Cerulean, said in a press release. “We will continue to work closely with the FDA with the goal of bringing CRLX101 to people living with cancer as quickly as possible.”