Dive Brief:
Iovance Biotherapeutics said it doesn't expect to seek U.S. approval of the experimental cancer cell therapy lifileucel until 2022 after failing to convince regulators that its potency testing is adequate.
The California biotech had once hoped to file its application with the Food and Drug Administration last year and made plans in 2019 to build a $75 million plant in Philadelphia to support production. After the FDA raised objections to Iovance's so-called potency assays — lab tests meant to measure the strength of its treatment — the company pushed back its target application date to 2021.
Iovance said it's working to develop and validate new assays that will meet the FDA's requirements and now expects to submit the therapy for approval in the first half of next year. The company's shares dropped by more than 10% at the start of Wednesday trading and then fell further after the company separately disclosed its CEO will be resigning.