Onco-Summaries: Daily Oncology Updates at a Glance
Updated: Oct 5
30/09/2026
Atara Bio's partner Pierre Fabre Pharma, resubmits tab-cel BLA to FDA for EBV+ PTLD (Ref)
Atara Biotherapeutics announced that its partner, Pierre Fabre Pharmaceuticals, has resubmitted the Biologics License Application (BLA) for tabelecleucel (tab-cel; allogeneic, off-the-shelf Epstein-Barr virus (EBV)-specific cytotoxic T-cell immunotherapy) to the US FDA for the treatment of relapsed/refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) in adults and pediatric patients aged ≥2 years following solid organ or hematopoietic cell transplantation
The resubmission incorporates additional clinical and real-world evidence, including extended follow-up from the pivotal Phase 3 ALLELE study, supplemental patient data, expanded access program experience, data from an additional study, and commercial experience from Europe. The filing follows FDA feedback received during a Type A meeting held in April 2026.
The FDA is expected to provide a revised review timeline and PDUFA date following acceptance of the resubmitted application. If approved, Atara Biotherapeutics would be eligible to receive a $31 million regulatory milestone payment from Pierre Fabre Laboratories, in addition to future royalties and commercial milestone payments
Celcuity Announces US Commercial Launch of REVTORPYK (gedatolisib) (Ref)
Celcuity announced that REVTORPYK™ (gedatolisib; pan-PI3K/mTOR ("PAM") inhibitor) is now commercially available in the US following its FDA approval for patients with HR+/HER2−, PIK3CA wild-type, locally advanced or metastatic breast cancer that has progressed after at least one line of endocrine therapy in the metastatic setting
The approval covers use in combination with fulvestrant, with or without palbociclib
Approval was supported by Phase 3 VIKTORIA-1 data, where the gedatolisib-based triplet regimen reduced the risk of disease progression or death by 76%, while the doublet regimen reduced risk by 67%, versus fulvestrant alone in the PIK3CA wild-type population
As part of its commitment to patient access, Celcuity has launched REVTORPYK Support Services to facilitate patient access, reimbursement, copay assistance, and enrollment support
A separate supplemental NDA has been submitted for use in patients with PIK3CA-mutated HR+/HER2− advanced breast cancer, which could potentially expand the drug's addressable patient population if approved
Comments