epstein barr virus positive b cell lymphoproliferative disorder complicated by septic shock in activated pi3k syndrome a pediatric case report and literature review

Original title: “Epstein-Barr Virus-Positive B-Cell Lymphoproliferative Disorder Complicated by Septic Shock in Activated PI3Kδ Syndrome: A Pediatric Case Report and Literature Review.”

touch smear cytology in epstein barr virus positive nodal t and nk cell lymphoma cytological features of this rare aggressive lymphoma

Original title: “Touch Smear Cytology in Epstein-Barr Virus-Positive Nodal T- and NK-Cell Lymphoma: Cytological Features of This Rare, Aggressive Lymphoma.”

We are concerned that this decision ... of rare disease treatments, effectively creating barriers for generating clinical evidence within a unique patient population with ultra-rare conditions thereby significantly delaying—or preventing altogether— patient access to urgently needed therapies…... We are concerned that this decision may have far-reaching consequences for the development of rare disease treatments, effectively creating barriers for generating clinical evidence within a unique patient population with ultra-rare conditions thereby significantly delaying—or preventing altogether— patient access to urgently needed therapies…. The FDA has issued a new complete response letter to Atara Biotherapeutics' regarding its biologics license application (BLA) for allogeneic Epstein-Barr virus (EBV)–specific T-cell immunotherapy tabelecleucel (tab-cel; marketed as Ebvallo) for the treatment of patients 2 years or older with EBV-positive posttransplant lymphoproliferative disease (EBV+ PTLD) who have received at least 1 prior therapy.1 · The CRL indicates that the FDA did not find the data from the pivotal phase 3 ALLELE clinical trial (NCT03394365) supporting the BLA to provide sufficient evidence of tab-cel’s efficacy. The CRL indicates that the ALLELE clinical trial does not sufficiently show efficacy of the product. We intend to engage with the FDA to urgently pursue a path forward, in collaboration with Atara Biotherapeutics and our clinical and patient partners, to enable timely accelerated approval of tabelecleucel. We continue to be committed to making tabelecleucel available to patients through our Expanded Access Program.” · Tab-cel has previously been approved in the European Union, the United Kingdom, and Switzerland for the treatment of relapsed/refractory EBV+ PTLD in patients aged 2 years and older who have received at least 1 prior therapy.3 Notably, Atara stated in January 2025 that a manufacturing facility operated by FUJIFILM Diosynth Biotechnologies and located in Thousand Oaks, California, had received approval to manufacture tab-cel for the European Medicines Agency.4

Original title: “FDA Hits Atara Biotherapeutics’ T-Cell Immunotherapy Tabelecleucel for EBV+ PTLD With Second CRL | CGTlive®”