Atara Biotherapeutics Ebvallo (tabelecleucel) Receives EC’s Approval for Epstein‑Barr Virus Positive Post‑Transplant Lymphoproliferative Disease
Shots:
• The EC has granted marketing authorization for Ebvallo as a monotx. in adult and pediatric patients aged ≥2yrs. with r/r EBV+ PTLD who have received one prior therapy.
• The opinion was based on the P-III study (ALLELE) study evaluating the efficacy & safety of tabelecleucel in 66 patients with EBV + PTLD after the failure of rituximab & rituximab + CT (SOT cohort) or HCT after the failure of rituximab (HCT cohort). The results demonstrated a favorable risk-benefit profile
• The CHMP issued a positive opinion & applies to all 27 EU member states, Iceland, Norway & Liechtenstein. Under the licens agreement with Atara, Pierre Fabre will be responsible for all commercialization & distribution activities in the EU & other markets
Ref: businesswire | Image: businesswire
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
