Iovance Biotherapeutics Inc. (IOVA) shares tumbled Tuesday after the cancer drug developer said it will delay its application to the Food & Drug Administration for an experimental treatment until later next year.
Iovance said that while its confident in the data its seeing from trials of lifileucel, a developing drug aimed at patients suffering from metastatic melanoma, a form of skin cancer, it has been unable to agree with the FDA on a timeline for its formal Biologics License Application.
Originally planned for this year, Iovance said late Monday that the BLA application will likely come in 2021, with an additional timing update provided 'when available'.
“TIL is a first-in-class, one-time administration cell therapy targeting solid tumors. As such, definition of the product through a potency assay is an important step toward submission of the BLA,” said CEO Maria Fardis. “We have agreement with the FDA regarding the amount of clinical follow up for the BLA, and we will work closely with the FDA to reach alignment on our assays."
"Because Iovance recognizes the significant unmet need in the melanoma patient population and believes the compelling clinical data for lifileucel will offer a new therapy for such patients, we are moving ahead with a great sense of urgency," he added. "We look forward to further collaboration with the FDA and will provide updates as they become available.”
Iovance shares were marked 15.44% lower in early trading following the FDA delay to change hands at $26.90 each, a move that would take the stock back to levels last seen in early March.