On February 26, 2019 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LN-145 for the treatment of patients with recurrent, metastatic or persistent cervical cancer who have progressed while on or after chemotherapy (Press release, Iovance Biotherapeutics, FEB 26, 2019, View Source;p=RssLanding&cat=news&id=2389051 [SID1234533762]). LN-145 is the Company’s adoptive cell therapy produced using its proprietary TIL manufacturing technology.
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"We are pleased to have received Fast Track designation for LN-145 for the treatment of cervical cancer in patients who have failed chemotherapy treatment," commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance Biotherapeutics. "The designation is an important positive step for the development of LN-145 in a serious and unmet medical need patient population. We are excited about the clinical data for LN-145 in cervical cancer patients and look forward to a closer collaboration with the FDA as we advance the clinical development of LN-145 for the treatment of cervical cancer."
The Fast Track designation from the FDA is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, which includes providing a therapy that may be potentially better than the available ones. With the Fast Track designation for LN-145, Iovance is expected to have more frequent meetings and communication with the FDA and is eligible, if relevant criteria are met upon submission, for a Rolling Review of the Biologic License Application (BLA) and potentially Accelerated Approval.1
The Company had previously reported preliminary data from the Phase 2 study of LN-145 for cervical cancer (C-145-04) in October 2018 for 15 patients yielding an overall response rate (ORR) of 27%. Patients in the study had a median of five prior therapies. The most common treatment-emergent adverse events included chills, pyrexia and anaemia. The protocol for the cervical cancer study has since been amended to limit the number of prior therapies to no more than three and to exclude patients who have been treated with prior immunotherapy. The study is actively recruiting patients at 32 clinical sites in the United States and Europe. The company anticipates providing an update on this study at an upcoming medical meeting in 2019.