Iovance gains 'Breakthrough' status for cervical cancer agent LN-145

Shares of US biotech Iovance Biotherapeutics (Nasdaq: IOVA) closed up 4.9% at $17.44, after the company revealed that the US Food and Drug Administration has granted Breakthrough Therapy designation for its TIL therapy candidate LN-145 in recurrent, metastatic, or persistent cervical cancer with disease progression on or after chemotherapy.

“We are very excited that the FDA has granted LN-145 in advanced cervical cancer Breakthrough Therapy designation. Cervical cancer patients who have progressed on or after chemotherapy have limited treatment options. We hope to bring LN-145 to these patients as quickly as possible,” commented Maria Fardis, president and chief executive of Iovance. “The designation allows us to expedite our development program through more frequent interactions with the FDA and provides eligibility for rolling review and priority review.”

Breakthrough Therapy designation is designed to expedite the development and review of therapeutic candidates intended to treat serious or life-threatening diseases in the case where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint.