Here’s a summary of the news article:
FDA Issues Second Complete Response Letter for Tabelecleucel
Atara Biotherapeutics received a second complete Response Letter from the FDA for its drug tabelecleucel, intended to treat adults and children (2+) with Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have already received at least one prior therapy.
Key Points:
* Previous Compliance Issue Resolved: The initial Complete Response Letter cited Good Manufacturing Practice (GMP) compliance issues, which Atara has as addressed.
* New Concern: Trial Design: The FDA now states the single-arm ALLELE trial is no longer sufficient to demonstrate efficacy and that its design could make data interpretation difficult.
* Atara’s Disappointment: Atara is surprised and disappointed by the decision, as they had previously aligned with the FDA on the trial data and design. They beleive the drug has the potential to considerably benefit patients.
* Orphan & Breakthrough Status: Tabelecleucel has both orphan drug designation and previously received breakthrough therapy status, highlighting the unmet need in this patient population.
* Future Plans: Atara intends to address the FDA’s concerns with the new clinical review team.
