- A committee of the European Medicines Agency ( EMA ) recommended the approval of Atara Biotherapeutics ( NASDAQ: ATRA ) and Pierre Fabre's Ebvallo as monotherapy to treat patients two years of age and older with relapsed or refractory Epstein?Barr virus positive post?transplant lymphoproliferative disease (EBV+ PTLD), who have received at least one prior therapy.
- For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.
- PTLD is a life-threatening complication following solid organ or bone marrow transplantation.
- The EMA's Committee for Medicinal Products for Human Use (CHMP) on Friday said that, if approved, Ebvallo (tabelecleucel) would be the first therapy to treat transplant patients with PTLD.
- The company said in its release that the CHMP positive opinion was backed by data from a phase 3 trial called ALLELE.
- The company expects the decision of the European Commission (EC), which generally follows the opinion of the CHMP, for Ebvallo's approval in Q4 2022.
- ATRA +0.75% to $4.02 premarket Oct. 14
For further details see:
EMA panel backs approval of Atara's Ebvallo for transplant complication