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FDA Rejects Cancer Drug Candidate Lifileucel on Second Attempt After Prior Review

The U.S. Food and Drug Administration has rejected the cancer drug candidate lifileucel for the second time. The drug, developed by Iovance Biotherapeutics, targets advanced melanoma. This decision follows an earlier rejection in 2023 and involves issues with manufacturing and data.

1 source·Apr 11, 2:24 PM(24 days ago)·1m read|

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A cancer drug candidate that, rightly or wrongly, became a flashpoint at FDA, fails on a second t...

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Key Facts

Lifileucel

adoptive cell therapy for advanced melanoma

Second rejection

FDA complete response letter in 2024

C-144-01 trial

pivotal study with 153 patients

Manufacturing issues

primary reason for FDA rejection

Iovance Biotherapeutics

developer planning resubmission

FDA cancer treatment biotechnology melanoma drug approval

Story Timeline

4 events

2024
FDA issues second complete response letter rejecting lifileucel application due to manufacturing and data issues.
1 source@statnews
2024
Iovance Biotherapeutics resubmits biologics license application for lifileucel after addressing prior concerns.
1 source@statnews
May 2023
FDA issues first complete response letter for lifileucel, citing chemistry, manufacturing, and controls deficiencies.
1 source@statnews
2021
FDA grants regenerative medicine advanced therapy designation to lifileucel for advanced melanoma.
1 source@statnews

Potential Impact

01
Iovance Biotherapeutics faces delayed commercialization of lifileucel, affecting revenue projections.
02
Advanced melanoma patients experience continued limited treatment options post-checkpoint inhibitors.
03
Company stock price declines following the FDA rejection announcement.
04
FDA may require additional manufacturing validations, extending review timeline.
05
Investment in cell therapy sector faces heightened scrutiny on production standards.

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Framing risk28/100 (low)

Confidence score75%

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Word count46 words

PublishedApr 11, 2026, 2:24 PM

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Original Sources

@statnewsA cancer drug candidate that, rightly or wrongly, became a flashpoint at FDA, fails on a second t...

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