The dream of an “off-the-shelf” T-cell therapy has become a reality, courtesy of the allogeneic aficionados over at Atara Biotherapeutics.
Monday, the company’s allogeneic Epstein-Barr virus-positive (EBV) T-cell therapy tabelecleucel snagged a world-first approval in Europe, where it’ll assume the commercial moniker Ebvallo.
Atara’s drug—which harnesses T-cells from healthy donors, unlike autologous cell therapies such as Bristol Myers Squibb’s Abecma, has been cleared by the European Commission as a monotherapy for patients ages two and up with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who’ve tried at least one other drug. For solid organ transplant patients, chemotherapy qualifies as a prior therapy unless that treatment route is inappropriate for the patient.
The approval was to be expected following an October blessing from the European Medicine Agency’s human medicines committee (CHMP). The green light clears the way for Ebvallo to debut in all 27 European Union member states, as well as Iceland, Norway and Lichtenstein. Further, under a recently amended commercialization accord with Pierre Fabre, Atara is poised to receive a $30 million milestone payment for snaring EU approval.
Under the Ebvallo licensing pact, Pierre Fabre will lead the charge on “all” commercialization and distribution efforts in Europe and “select other markets.” The French pharma will also handle medical and regulatory activities once Ebvallo marketing authorization is transferred from Atara, the companies explained in a release.
Not only the first allogeneic T-cell therapy, Ebvallo also marks the first green light in Europe for patients with the rare and deadly form of cancer EBV+ PTLD.
San Francisco-based Atara needed this win following a rocky year attempting to advance its T-cell treatments.
Notably, a patient death in Atara’s trial of an autologous T-cell candidate prompted a study enrollment halt and sent Bayer packing from a $670 million partnership.
That said, Atara had good news to share over the summer. After the FDA previously recommended Atara run a new clinical trial for Ebvallo, the company reported in August that the agency identified a potential path toward a submission without a new study.
While a European nod doesn’t necessarily mean the Ebvallo will win the FDA’s blessing, “it certainly can’t hurt as the FDA regularly pays attention to its regulatory counterpart and its decisions,” Mizuho Securities analysts wrote in a note to clients Monday. The team pointed out that Atara will provide more clarity on its U.S. application in the first quarter of 2023.
As for Ebvallo’s pricing in the commercial realm, “there is no update” as of yet, though Atara has mentioned previous bookends between a CAR-T cell therapy (about $400,000) and Novartis’ gene therapy Zolgensma, which costs around $2.1 million.
By Fraiser Kansteiner
Source: fiercepharma.com
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