The FDA has granted priority review of the biologics license application (BLA) for tabelecleucel (tab-cel) as a monotherapy to treat adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD). The Prescription Drug User Fee Act (PDUFA) target action date is Jan. 15, 2025.
Lymphoproliferative disease is a rare but life-threatening complication after organ or stem-cell transplants. Many cases are associated with Epstein-Barr virus, accounting for more than 75% of post-transplant lymphoproliferative disease, according to one estimate. Most people have been infected with Epstein-Barr at some point in their lives. The immune suppression used after a transplant can reactivate the virus, causing B cells to grow uncontrollably.
There is no treatment available specifically for Epstein-Barr virus related post-transplant lymphoproliferative disease, but Rituxan (rituximab) and chemotherapy are often used to treat the disease.
Developed by Atara Biotherapeutics, tab-cel is an allogeneic, T-cell immunotherapy designed to target and eliminate cells infected with Epstein-Barr virus. If approved, it would be indicated for those patients who been treated with at least one other therapy.
The FDAs granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate, Pascal Touchon, president and CEO of Atara, said in a news release.
The BLA is supported by data from more than 430 patients treated with tab-cel across multiple life-threatening diseases, including the pivotal ALLELE study that met its primary endpoint. Interim data from this study found that 22 of 43 (51.2%) Epstein-Barr virus related post-transplant lymphoproliferative disease patients achieved an objective response rate (ORR). The median duration of response was 23 months and the median overall survival was 18.4 months.
Tab-cel was well tolerated with no reports of tumor flare reaction, cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, and there were no events of graft-versus-host disease or solid organ transplant rejection related to treatment. These data werepreviously presentedat the 2022 American Society of Hematology (ASH) Annual Meeting.
An updated analysis from the October 2023 data cut off of the ALLELE study continued to demonstrate a statistically significant 49% ORR. These data were presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.
Tab-cel is approved in Europe with the brand name Ebvallo.
Atara has partnered with Pierre Fabre Laboratories for development, manufacturing, and commercialization rights in Europe and the United States. The FDAs BLA acceptance has triggered a $20 million milestone payment from Pierre Fabre Laboratories to Atara, with an additional $60 million milestone payment if approved by the FDA.
See original here:
FDA Sets Review Date for Cell Therapy for Post-Transplant Complication - Managed Healthcare Executive
- Stem Cell Therapy for Kidney Failure [Last Updated On: April 1st, 2011] [Originally Added On: April 1st, 2011]
- Dogged by pain -- stem cell therapy for dogs [Last Updated On: June 24th, 2013] [Originally Added On: April 3rd, 2011]
- Dogs now getting stem cell therapy [Last Updated On: April 8th, 2011] [Originally Added On: April 8th, 2011]
- Stem Cells for Spinal Cord Injury: Community Outreach San Diego 2011 - Trish Stressman [Last Updated On: April 11th, 2011] [Originally Added On: April 11th, 2011]
- Stem Cell Treatment Doing Wonders For Autistic Boy [Last Updated On: April 14th, 2011] [Originally Added On: April 14th, 2011]
- Is Stem Cell Therapy right for your pet [Last Updated On: April 14th, 2011] [Originally Added On: April 14th, 2011]
- Regenerative Medicines [Last Updated On: May 19th, 2011] [Originally Added On: May 19th, 2011]
- Stem Cell Therapy for Multiple Sclerosis [Last Updated On: June 24th, 2013] [Originally Added On: May 20th, 2011]
- Adult Stem Cell Therapy for Multiple Sclerosis [Last Updated On: May 23rd, 2011] [Originally Added On: May 23rd, 2011]
- Heart Failure Patient After Adult Stem Cell Therapy [Last Updated On: June 24th, 2013] [Originally Added On: May 30th, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia [Last Updated On: June 24th, 2013] [Originally Added On: June 2nd, 2011]
- Stem Cell Therapy For Alzheimer's/Dementia [Last Updated On: June 7th, 2011] [Originally Added On: June 7th, 2011]
- Stem Cell Therapy Injections [Last Updated On: June 24th, 2013] [Originally Added On: June 8th, 2011]
- Clinical Advances in Adult Stem Cell Therapy: Dr. Jorge Paz [Last Updated On: June 24th, 2013] [Originally Added On: June 11th, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl [Last Updated On: June 12th, 2011] [Originally Added On: June 12th, 2011]
- Stem Cell Therapy MS: Sam Harrell and The Superbowl [Last Updated On: June 24th, 2013] [Originally Added On: June 14th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Rationale [Last Updated On: June 14th, 2011] [Originally Added On: June 14th, 2011]
- Stem Cell Injection Treatment - Stem Cell Therapy [Last Updated On: June 18th, 2011] [Originally Added On: June 18th, 2011]
- edivet America Dog Arthritis Stem Cell Therapy Stem Cell Therapy for Equine 1 [Last Updated On: June 24th, 2013] [Originally Added On: June 23rd, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Approach [Last Updated On: June 25th, 2011] [Originally Added On: June 25th, 2011]
- Adult Stem Cell Therapy Clinical Advances - Dr. Jorge Paz in San Diego, CA March 2011 [Last Updated On: July 3rd, 2011] [Originally Added On: July 3rd, 2011]
- Adult Stem Cell Therapy Clinical Advances - Dr. Jorge Paz in San Diego, CA March 2011 [Last Updated On: June 24th, 2013] [Originally Added On: July 15th, 2011]
- Duffy Gets Stem Cell Therapy [Last Updated On: June 24th, 2013] [Originally Added On: July 15th, 2011]
- WAVE3 News Adipose Stem Cell Therapy [Last Updated On: June 24th, 2013] [Originally Added On: July 16th, 2011]
- Lou Gehrig's Disease (ALS): UCSD Team's Stem Cell Therapy Approach [Last Updated On: June 24th, 2013] [Originally Added On: July 16th, 2011]
- Clinical Advances in Adult Stem Cell Therapy - Dr. Jorge Paz Rodriguez (Miami) [Last Updated On: June 24th, 2013] [Originally Added On: July 21st, 2011]
- Stem Cell Therapy for Cerebral Palsy - Holly Catalano [Last Updated On: June 24th, 2013] [Originally Added On: August 2nd, 2011]
- Bone Marrow Aspiration - Stem Cell Therapy [Last Updated On: August 5th, 2011] [Originally Added On: August 5th, 2011]
- Dr. Chein discusses Autologous Stem Cell Therapy - Palm Springs [Last Updated On: June 24th, 2013] [Originally Added On: August 12th, 2011]
- Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com [Last Updated On: June 24th, 2013] [Originally Added On: August 14th, 2011]
- Dr. Craig Saunders Adult Stem Cell Therapy [Last Updated On: August 15th, 2011] [Originally Added On: August 15th, 2011]
- Embryonic stem cell therapy in China (www.esctherapy.com) [Last Updated On: June 24th, 2013] [Originally Added On: August 16th, 2011]
- Ying Liu discusses IPS cell therapy for ALS [Last Updated On: June 24th, 2013] [Originally Added On: August 16th, 2011]
- Stem Cell Therapy: Healing Force of the future [Last Updated On: September 19th, 2011] [Originally Added On: September 19th, 2011]
- Benefits of STEM CELL THERAPY - Adipose Tissue [Last Updated On: September 22nd, 2011] [Originally Added On: September 22nd, 2011]
- Stem Cell Therapy Skin Repair and Anti-Wrinkle Cream [Last Updated On: June 24th, 2013] [Originally Added On: September 24th, 2011]
- Cardiac Stem Cell Therapy [Last Updated On: June 24th, 2013] [Originally Added On: September 24th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach Dallas, TX 2011 [Last Updated On: June 24th, 2013] [Originally Added On: September 24th, 2011]
- Stroke Victim Improved With Stem Cell Therapy. More at http://www.stemcellfusion.com [Last Updated On: September 25th, 2011] [Originally Added On: September 25th, 2011]
- A Touch of Love® - Stem Cell Therapy for Pets-Dr. Danny DeRose-Part 3 [Last Updated On: September 27th, 2011] [Originally Added On: September 27th, 2011]
- Adult Stem Cell Therapy for Multiple Sclerosis [Last Updated On: June 24th, 2013] [Originally Added On: September 28th, 2011]
- Multiple Sclerosis Stem Cell Therapy News Coverage [Last Updated On: June 24th, 2013] [Originally Added On: October 1st, 2011]
- The Spinal Cord Journey - Stem cell therapy stories from three spinal cord injury patients [Last Updated On: October 6th, 2011] [Originally Added On: October 6th, 2011]
- Peyton Manning Stem Cell Therapy: Some Doctors Cry Foul Over European Treatment - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- Stem-Cell-Therapy-in-China.wmv - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- Randolph veterinarian uses new stem cell therapy on ailing pets - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 13th, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 14th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach Dallas, TX 2011 - Video [Last Updated On: October 14th, 2011] [Originally Added On: October 14th, 2011]
- Affordable Stem Cell Therapy in Guatemala (2hrs from Miami) - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 15th, 2011]
- Stem Cell Research: Macular Degeneration - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- Duffy Gets Stem Cell Therapy - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- VetCell's StemRegen - the original and best stem cell therapy for equine tendon injuries - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- Macular degeneration - Stem Cell therapy (English subtitles) - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- Stem Cell Therapy for Rheumatoid Arthritis - Community Outreach Dallas - Darnell Morris - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 21st, 2011]
- Adult Stem Cell Therapy for Congestive Heart Failure [Last Updated On: June 24th, 2013] [Originally Added On: October 21st, 2011]
- Stem Cell Therapy for Critical Limb Ischemia: First Choice or Last Ditch? - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- WAVE3News Adipose Stem Cell Therapy - Video [Last Updated On: October 22nd, 2011] [Originally Added On: October 22nd, 2011]
- Stem Cell Therapy in Cardiac Disease - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 24th, 2011]
- Stem Cell Treatment for Autism: Community Outreach Miami, Florida - May 2011 - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 24th, 2011]
- Pre Post n 6 Months Post Stem Cell Therapy of Dystonic Cerebral Palsy - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 24th, 2011]
- Stem Cell Treatment for Rheumatoid Arthritis - "I am basically pain free." - Video [Last Updated On: October 26th, 2011] [Originally Added On: October 26th, 2011]
- UMBILICAL CORD STEM CELL THERAPY - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 26th, 2011]
- Stem Cell Therapy for Peripheral Artery Disease - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 26th, 2011]
- Multiple Sclerosis Adult Stem Cell Therapy - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 26th, 2011]
- Stem Cell Therapy for Multiple Sclerosis Stimulates IDO - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 26th, 2011]
- HIV/AIDS: Spotlight on Stem Cell Research - John Zaia - Video [Last Updated On: October 26th, 2011] [Originally Added On: October 26th, 2011]
- Stem cell treatment by Adiva Health Care India after Spinal Cord Injury - Video [Last Updated On: October 27th, 2011] [Originally Added On: October 27th, 2011]
- Stem Cell Treatment for Spinal Cord Injury - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Lou Gehrig's Disease: Stem Cell Therapy Pre-Clinical Studies - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Stem Cell Treatment for Spinal Cord Injury - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 28th, 2011]
- Holly Huber on Recovery: Stem Cell Therapy for Multiple Sclerosis Community Outreach San Diego CA - Video [Last Updated On: June 24th, 2013] [Originally Added On: October 28th, 2011]
- Stem Cell Treatment for Rheumatoid Arthritis - "I got my life back" - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Adult Stem Cell Therapy Following Heart Attack and Stroke - Video [Last Updated On: October 28th, 2011] [Originally Added On: October 28th, 2011]
- Stem Cells - Treatment for Autism - Video [Last Updated On: November 2nd, 2011] [Originally Added On: November 2nd, 2011]
- Stem Cell Treatment Diabetes - Video [Last Updated On: November 7th, 2011] [Originally Added On: November 7th, 2011]
- Stem Cell Therapy: Psoriatic Arthritis Treatment - Video [Last Updated On: June 24th, 2013] [Originally Added On: November 8th, 2011]
- Stem Cell Therapy Cure Hair Loss. More at http://www.stemcellfusion.com - Video [Last Updated On: June 24th, 2013] [Originally Added On: November 10th, 2011]
- BioLogic Stem Cell Therapy - Video [Last Updated On: November 16th, 2011] [Originally Added On: November 16th, 2011]
- BioLogic Stem Cell Therapy - Video [Last Updated On: June 24th, 2013] [Originally Added On: November 16th, 2011]
- AVS Stem Cell Therapy - Video [Last Updated On: June 24th, 2013] [Originally Added On: November 17th, 2011]