With a thumbs up from Europe’s Committee for Medicinal Products for Human Use (CHMP), Atara Biotherapeutics’ Ebvallo is poised to become the first allogeneic T-cell therapy approved in the world.
Premanufactured from unrelated donor cells, Ebvallo differs from current autologous T-cell therapies—such as Bristol Myers Squibb’s Abecma and Breyanzi and Gilead’s Yescarta and Tecartus—which are derived from a patient's own immune cells.
The positive recommendation comes for the treatment of Epstein-Barr virus-positive, post-transplant lymphoproliferative disease in patients who have undergone at least one prior therapy—most often chemotherapy for solid organ transplant recipients. After the CHMP decision, Atara expects a formal sign-off from the European Commission this year.
Under a recently amended commercialization deal with Pierre Fabre, the company stands to get a $30 million milestone payment upon European approval.
Ebvallo's forthcoming approval stands to become landmark achievement for the San Francisco-based company after a difficult year attempting to advance its T-cell treatments.
After a patient died in Atara’s trial of an autologous T-cell candidate, enrollment in the study was halted and commercial partner Bayer pulled out of a $670 million partnership.
But the company did disclose a piece of good news from the FDA this summer. After the agency previously recommended Atara run a clinical trial for Ebvallo with finished commercial product, the company reported in August that the agency has identified a potential path toward a submission without a new trial.
The CHMP recommendation is “further validation for our unique EBV T-cell platform,” Atara CEO Pascal Touchon said in a release. “(Ebvallo) has the potential to change the treatment paradigm for patients with relapsed or refractory EBV+ PTLD who face a poor prognosis and dismal median survival of only weeks to a few months.”
Other CHMP decisions
It wasn't just Atara making news at CHMP this week. Regeneron has secured a positive opinion for Libtayo for the treatment of cervical cancer. Already approved in Europe and the U.S for basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer, Libtayo is the first treatment to demonstrate improved survival to chemotherapy in second-line setting regardless of PD-L1 expression status or tumor histology, Regeneron said.
Also receiving a CHMP blessing is Mirum Pharmaceuticals for Livmarli to treat patients with the rare, progressive liver disease Alagille syndrome. Livmarli won U.S. approval in September of last year. San Francisco-based Mirum is in a battle with Albireo’s Bylvay to treat three pediatric liver disorders.
The CHMP also recommended approvals for Eladynos’ abaloparatide for the treatment of osteoporosis; Spevigo’s spesolimab for pustular psoriasis; Pluvicto’s lutetium for prostate cancer; and Locametz’s gozetotide, a radiopharma agent to diagnose prostate cancer.
Three generics also got nods—Teva’s dimethyl fumarate for MS, Baxter’s pemetrexed for mesothelioma and Accord’s plerixafor for lymphoma and multiple myeloma.