On August 31, 2017 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-144, the Company’s adoptive cell therapy using its TIL technology, for the treatment of advanced melanoma (Press release, Iovance Biotherapeutics, AUG 31, 2017, View Source [SID1234520352]).
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"We are pleased that the FDA has granted Fast Track designation to LN-144 for the treatment of advanced melanoma. The Fast Track designation underscores that advanced melanoma remains a serious condition and that LN-144 may have the potential to address this unmet medical need," said Dr. Maria Fardis, PhD, MBA, Chief Executive Officer of Iovance Biotherapeutics. "We look forward to a closer interaction with the FDA as we advance the clinical development of LN-144 for the treatment of advanced melanoma."
C-144-01 is a Phase 2 study evaluating LN-144, Iovance’s lead product, for treatment of patients with metastatic melanoma. The study is currently enrolling and is expected to enroll up to 60 patients in two cohorts: Cohort 1 allows for non-cryopreserved TIL product to be administered to patients, while Cohort 2 involves administration of a cryopreserved product. In June 2017, the Company presented a poster at the 2017 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting with data from 16 patients enrolled in the first cohort of this study. The data reported showed clinically-meaningful outcomes in the evaluable patients, with a 29% Objective Response Rate (per RECIST v1.1) including one complete response continuing beyond 15 months post-administration of a single TIL treatment, and 77% of patients had reduction in target tumor size. The Phase 2 study was conducted in a heavily pre-treated patient group, all of which had received prior anti-PD-1 therapy and 88% with prior anti-CTLA-4 checkpoint inhibitors, with a median of three prior therapies.
The FDA’s Fast Track process is designed to facilitate the development, and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Fast Track designation allows more frequent meetings and communications with the FDA to discuss the drug’s development plans and review process. The Fast Track designation also allows for a rolling review of a company’s Biologic License Application (BLA).