Iovance Biotherapeutics Announces Breakthrough Therapy Designation for LN-145 for Treatment of Advanced Cervical Cancer Patients Who Have Progressed on or After Chemotherapy

 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Iovance 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, Ph.D., MBA, president and chief executive officer 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 (BTD) 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. The FDA decision on BTD for LN-145 in advanced cervical cancer was based on clinical data from the ongoing innovaTIL-04 (C-145-04) trial. The company will present the data on June 1, 2019, at the American Society of Clinical Oncology (ASCO) Annual Meeting.

About Iovance Biotherapeutics, Inc.

Iovance Biotherapeutics intends to commercialize lifileucel, an autologous cell therapy product using TIL technology that amplifies the body’s own immune response to eradicate solid tumors or attack blood cancers. The company is currently conducting the pivotal study innovaTIL-01 in patients with metastatic melanoma. In addition, the company’s TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including cervical, head and neck, and non-small cell lung cancer.

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