EbvalloTM on Track to be the First Ever Allogeneic
T-Cell Therapy Approved
Positive Opinion Based on Pivotal Phase 3 ALLELE Study
Demonstrating a Favorable Risk-Benefit Profile
European Commission Approval Expected in Q4 2022
SAN
FRANCISCO and CASTRES, France, Oct. 14,
2022 /PRNewswire/ -- Atara Biotherapeutics,
Inc. (Nasdaq: ATRA) and Pierre
Fabre today announced the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has
adopted a positive opinion recommending the European Commission
(EC) approval of EbvalloTM (tabelecleucel) as a
monotherapy for treatment of adult and pediatric 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.
![(PRNewsfoto/Atara,Pierre Fabre) (PRNewsfoto/Atara,Pierre Fabre)](https://mma.prnewswire.com/media/1921422/Atara_and_Pierre_Fabre_Logo.jpg)
"Today's positive CHMP opinion is a major step forward for
Atara's first-in-class product that addresses an ultra-rare and
aggressive cancer with no approved therapies while providing
further validation for our unique allogeneic EBV T-cell platform,"
said Pascal Touchon, President and
CEO of Atara. "If approved, EbvalloTM will be the first
ever allogeneic T-cell therapy and 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."
The CHMP positive opinion is based on results from the pivotal
Phase 3 ALLELE study.[1] In this study,
EbvalloTM demonstrated a favorable risk-benefit
profile.
"This positive opinion is a landmark moment for patients
suffering from an extremely rare cancer," said Eric Ducournau, CEO of Pierre Fabre, Atara's commercialization partner
in Europe. "EbvalloTM
is on track to be the first ever allogeneic T-cell therapy approved
in the European Union. Our teams are excited and poised to bring
this first-in-kind innovation to European patients, as a testimony
to our corporate purpose: every time we care for a single person,
we make the whole world better."
"All patients undergoing transplant are at risk of developing
EBV+ PTLD during their life, and in that case, those that do not
respond to initial treatment have few treatment options left," said
Dr. Sylvain Choquet, Head of the
Clinical Hematology Department at Pitié-Salpêtrière, APHP,
France. "There is an urgent unmet
need for effective therapies for this rare B-cell
lymphoproliferative disease, with data from the pivotal study
demonstrating the potential for EbvalloTM to change the
treatment of relapsed or refractory EBV+ PTLD and provide a
much-needed therapeutic solution to both patients and
physicians."
With the CHMP positive opinion, the EC's approval of the
EbvalloTM Marketing Authorization Application (MAA)
under exceptional circumstances is expected by the end of 2022. If
granted by the EC, the centralized marketing authorizations would
be valid in all EU Member States as well as Iceland, Liechtenstein, and Norway. In addition, the MAA will be filed to
the Medicines and Healthcare Products Regulatory Agency (MHRA) in
the UK under the EC Decision Reliance Procedure (EC DRP) with an
expected approval by the end of 2022. Under an existing
collaboration agreement, Pierre
Fabre will lead all commercialization and distribution
activities in Europe and select
other markets in addition to medical and regulatory activities
after the anticipated MAA approval in Europe.
About EbvalloTM and EBV+
PTLD
EbvalloTM is an allogeneic, EBV-specific T-cell
immunotherapy which targets and eliminates EBV-infected cells in an
HLA-restricted manner. EbvalloTM (tabelecleucel) has
been granted Breakthrough Therapy Designation for the treatment of
rituximab-refractory EBV-associated lymphoproliferative disease
(LPD) by the U.S. Food and Drug Administration (FDA) and has orphan
drug designation in the U.S. EbvalloTM (tabelecleucel)
received PRIME designation by the European Medicines Agency (EMA)
for the treatment of patients with EBV-associated PTLD in the
allogeneic hematopoietic stem cell transplant (HCT) setting who
have failed on rituximab and has orphan drug designation in the EU.
EBV+ PTLD is a rare, acute, and potentially deadly hematologic
malignancy that occurs after transplantation when a patient's
T-cell activity is compromised by immunosuppression. It can impact
patients who have undergone solid organ transplant (SOT) or an
allogeneic HCT. Poor median survival of 0.7 months and 4.1 months
for HCT and SOT, respectively, is reported in EBV+ PTLD patients
for whom rituximab ± chemotherapy failed, underscoring the
significant need for effective, safe, and fast-acting new
therapeutic options.
About Pierre Fabre
Pierre Fabre is a French
healthcare company with over 35-years of experience in innovation,
development, manufacturing and commercialization in oncology. Its
portfolio includes several medical franchises and international
brands, namely Pierre Fabre Oncology, Pierre Fabre Dermatology,
Pierre fabre Health Care, Eau Thermale Avène, Klorane, René
Furterer, A-Derma, Darrow, Glytone, Naturactive and Pierre Fabre
Oral Care. The company has declared oncology its top priority in
medical care R&D and commercialization, focusing on targeted
therapies, biotherapies and immuno-oncology. Its portfolio covers
colorectal, breast, lung cancers, melanoma and pre-cancerous
conditions like actinic keratosis. Pierre
Fabre provides specific solutions to help patients manage
adverse side effects affecting the skin and mouth due to cancer
treatment. In 2021, Pierre Fabre
posted 2.5 billion euros in revenues,
66% of which came from international sales in over 100
countries.
Established in the South-West of France since its creation, the group
manufactures over 95% of its products in France and employs some 9,600 people
worldwide. Pierre Fabre is 86%-owned
by the Pierre Fabre Foundation, a government-recognized
public-interest foundation since 1999, and secondarily by its own
employees through an international employee stock ownership plan.
Further information about Pierre
Fabre can be found at www.pierre-fabre.com,
@PierreFabre.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in
T-cell immunotherapy leveraging its novel allogeneic EBV T-cell
platform to develop transformative therapies for patients with
serious diseases including solid tumors, hematologic cancers and
autoimmune disease. With our lead program in Phase 3 clinical
development, Atara is the most advanced allogeneic T-cell
immunotherapy company and intends to rapidly deliver off-the-shelf
treatments to patients with high unmet medical need. Our platform
leverages the unique biology of EBV T cells and has the capability
to treat a wide range of EBV-associated diseases, or other serious
diseases through incorporation of engineered CARs (chimeric antigen
receptors) or TCRs (T-cell receptors). Atara is applying this one
platform, which does not require TCR or HLA gene editing, to create
a robust pipeline including: tab-cel in Phase 3 development for
Epstein-Barr virus-driven post-transplant lymphoproliferative
disease (EBV+ PTLD) and other EBV-driven diseases; ATA188, a T-cell
immunotherapy targeting EBV antigens as a potential treatment for
multiple sclerosis; and multiple next-generation chimeric antigen
receptor T-cell (CAR-T) immunotherapies for both solid tumors and
hematologic malignancies. Improving patients' lives is our mission
and we will never stop working to bring transformative therapies to
those in need. Atara is headquartered in South San Francisco.
For additional information about the company, please
visit atarabio.com and follow us
on Twitter and LinkedIn.
INVESTOR & MEDIA CONTACTS:
Atara:
Investors
Eric
Hyllengren
ehyllengren@atarabio.com
Media
Alex
Chapman
achapman@atarabio.com
Pierre Fabre:
Laure Sgandurra
laure.sgandurra@pierre-fabre.com
[1] https://doi.org/10.1182/blood-2021-147274
Logo -
https://mma.prnewswire.com/media/1921422/Atara_and_Pierre_Fabre_Logo.jpg
View original content to download
multimedia:https://www.prnewswire.co.uk/news-releases/chmp-recommends-approval-of-atara-biotherapeutics-ebvallotm-tabelecleucel-for-the-treatment-of-epstein-barr-virus-positive-post-transplant-lymphoproliferative-disease-301649604.html