FDA grants fast track designation to motolimod for platinum-resistant ovarian cancer

The FDA granted fast track designation to VTX-2337 in combination with pegylated liposomal doxorubicin for the treatment of ovarian cancer that has progressed on or recurred after platinum-based chemotherapy, the drug’s manufacturer announced.

VTX-2337 (motolimod, VentiRx Pharmaceuticals) is a novel Toll-like Receptor 8 agonist that directly activates several components of the innate immune system.

“The Fast Track designation is an important regulatory milestone for the motolimod program and underscores the potential for this novel agent to address a significant unmet medical need for women with ovarian cancer who have progressed on or recurred after receiving platinum-based chemotherapy,” Robert Hershberg, MD, PhD, president and CEO of VentiRx, said in a press release. “We look forward to emerging clinical data and to the possibility of providing a meaningful treatment for women with ovarian cancer.”

The FDA based its decision on preliminary data from a randomized, placebo-controlled phase 2 trial designed to assess clinical activity of VTX-2337 in combination with pegylated liposomal doxorubicin in 290 patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy.