FDA grants CRLX101 fast track designation to treat ovarian cancer

The FDA granted fast track designation to CRLX101 in combination with paclitaxel for the treatment of platinum-resistant ovarian carcinoma, fallopian tube cancer or primary peritoneal cancer.

A phase 1b/phase 2 clinical trial is underway to evaluate CRLX101 (Cerulean Pharma) — a nanoparticle-drug conjugate — in combination with weekly paclitaxel for the treatment of recurrent platinum-resistant ovarian carcinoma.

Data from the trial were presented at the Experts Meeting on Gynecologic Oncology conference in May. Results showed that five of the first nine patients who were treated achieved partial responses.

In addition, five of the nine patients previously failed treatment with bevacizumab (Avastin, Genentech), and three of these five patients achieved a partial response.

“We appreciate the FDA’s acknowledgement of CRLX101’s potential in an area of significant unmet medical need,” Christopher D. T. Guiffre, president and CEO of Cerulean, said in a press release. “We are encouraged by the profound treatment effect observed early in the ongoing clinical trial with the GOG Foundation, and we look forward to working closely with the FDA as we endeavor to bring a new treatment option to women living with platinum-resistant ovarian cancer.”

The FDA previously granted CRLX101 orphan drug designation for the treatment of ovarian cancer. The agent also has received fast track designation in combination with bevacizumab to treat metastatic renal cell carcinoma.