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Application is being reviewed
under FDA's Real-Time Oncology Review pilot programme
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Combination was granted
Breakthrough Therapy Designation, the fifth for Venclexta
Basel, 7 March 2019 - Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced the submission of a supplemental New Drug
Application to the US Food and Drug Administration (FDA) for
Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab)
in people with previously untreated chronic lymphocytic leukaemia
(CLL) and co-existing medical conditions. The FDA is reviewing the
application under the Real-Time Oncology Review pilot programme,
which aims to explore a more efficient review process to ensure
safe and effective treatments are available to patients as early as
possible.
"More than 20,000 people will be diagnosed with untreated chronic
lymphocytic leukaemia in the US this year, and many are ineligible
for intensive chemotherapy-based options," said Sandra Horning, MD,
Roche's Chief Medical Officer and Head of Global Product
Development. "We are encouraged that this chemotherapy-free,
fixed-duration combination is being reviewed under the FDA's
Real-Time Oncology Review pilot programme, and we are working
closely with the agency to bring this new option to people with
previously untreated chronic lymphocytic leukaemia as quickly as
possible."
Breakthrough Therapy Designation was granted based on results of
the randomised phase III CLL14 study, evaluating the fixed-duration
combination of Venclexta plus Gazyva, compared to Gazyva plus
chlorambucil, in people with previously untreated CLL and
co-existing medical conditions. The study met its primary endpoint
and showed a statistically significant reduction in the risk of
disease worsening or death (progression-free survival [PFS] as
assessed by investigator) compared to standard-of-care Gazyva plus
chlorambucil. Safety for the Venclexta plus Gazyva combination
appeared consistent with the known safety profiles of the
individual medicines, and no new safety signals were identified
with the combination. Data from the CLL14 study will be presented
at an upcoming medical meeting. The CLL14 study is being conducted
in cooperation with the German CLL Study Group (GCLLSG), headed by
Michael Hallek, MD, University of Cologne.
Venclexta is being developed by AbbVie and Roche. It is jointly
commercialised by AbbVie and Genentech, a member of the Roche
Group, in the US and commercialised by AbbVie, under the brand name
Venclyxto, outside of the US.
About the CLL14 study
CLL14 (NCT02242942) is a randomised phase III study evaluating the
combination of fixed-duration Venclexta plus Gazyva compared to
Gazyva plus chlorambucil in patients with previously untreated
chronic lymphocytic leukaemia (CLL) and co-existing medical
conditions. 432 patients with previously untreated CLL were
randomly assigned to receive either a 12-month duration of
Venclexta alongside six-month duration of Gazyva (Arm A) or
six-month duration of Gazyva plus chlorambucil followed by an
additional six-month duration of chlorambucil (Arm B). The primary
endpoint of the study is investigator-assessed progression-free
survival (PFS). Secondary endpoints include PFS assessed by
independent review committee (IRC), minimal residual disease (MRD)
status, overall response (OR), complete response (with or without
complete blood count recovery, CR/CRi), overall survival (OS),
duration of response (DOR), event-free survival (EFS), time to next
CLL treatment (TTNT), and safety. The CLL14 study is being
conducted in cooperation with the German CLL Study Group (GCLLSG),
headed by Michael Hallek, MD, University of Cologne.
About Venclexta/Venclyxto
(venetoclax)
Venclexta/Venclyxto is a first-in-class targeted medicine designed
to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2)
protein. In some blood cancers and other tumours, BCL-2 builds up
and prevents cancer cells from dying or self-destructing, a process
called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and
works to restore the process of apoptosis.
Venclexta/Venclyxto is being developed by AbbVie and Roche. It is
jointly commercialised by AbbVie and Genentech, a member of the
Roche Group, in the US and commercialised by AbbVie, under the
brand name Venclyxto, outside of the US. Together, the companies
are committed to research with Venclexta, which is currently being
studied in clinical trials across several types of blood and other
cancers.
In the US, Venclexta has been granted five Breakthrough Therapy
Designations by the FDA: in combination with Gazyva for people with
previously untreated chronic lymphocytic leukaemia (CLL) and
co-existing medical conditions; in combination with Rituxan for
people with relapsed or refractory CLL; as a monotherapy for people
with relapsed or refractory CLL with 17p deletion; in combination
with hypomethylating agents (azacitidine or decitabine) for people
with untreated acute myeloid leukaemia (AML) ineligible for
intensive chemotherapy; and in combination with low-dose cytarabine
for people with untreated AML ineligible for intensive
chemotherapy.
About Gazyva (obinutuzumab)
Gazyva is an engineered monoclonal antibody designed to attach to
CD20, a protein expressed on certain B cells, but not on stem cells
or plasma cells. Gazyva is designed to attack and destroy targeted
B-cells both directly and together with the body's immune system.
Gazyva is marketed as Gazyvaro in the EU and Switzerland.
Gazyva/Gazyvaro is currently approved in more than 90 countries in
combination with chlorambucil for people with previously untreated
chronic lymphocytic leukaemia, in more than 80 countries in
combination with bendamustine for people with certain types of
previously treated follicular lymphoma and in more than 70
countries in combination with chemotherapy for previously untreated
follicular lymphoma.
Additional combination studies investigating Gazyva/Gazyvaro with
other approved or investigational medicines, including cancer
immunotherapies and small molecule inhibitors, are underway across
a range of blood cancers.
About the German CLL Study Group
(GCLLSG)
Founded in 1996 and headed by Michael Hallek, MD, the GCLLSG has
been running various phase III, phase II and phase I trials in
chronic lymphocytic leukaemia (CLL) with the goal to provide
optimal treatment to patients suffering from this disease. Among
those were landmark trials like the CLL8 and the CLL11 trials which
led to the current standard of care in CLL. For many years, GCLLSG
has been aiming to improve not just the treatment of younger and
physically fit patients, but also that of elderly and less fit
patients. These patients are generally underrepresented in clinical
trials although they constitute the majority of CLL patients
treated by doctors in daily practice. The GCLLSG is an independent
non-profit research organisation supported by the German Cancer Aid
(Deutsche Krebshilfe) www.dcllsg.de.
About Roche in haematology
For more than 20 years, Roche has been developing medicines that
redefine treatment in haematology. Today, we are investing more
than ever in our effort to bring innovative treatment options to
people with diseases of the blood. In addition to approved
medicines MabThera®/Rituxan® (rituximab), Gazyva/Gazyvaro
(obinutuzumab), and Venclexta/Venclyxto (venetoclax) in
collaboration with AbbVie, Roche's pipeline of investigational
haematology medicines includes Tecentriq® (atezolizumab), an
anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and
a small molecule which inhibits the interaction of MDM2 with p53
(idasanutlin/RG7388). Roche's dedication to developing novel
molecules in haematology expands beyond malignancy, with the
development of Hemlibra® (emicizumab), a bispecific monoclonal
antibody for the treatment of haemophilia A.
About Roche
Roche is a
global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths
of pharmaceuticals and diagnostics under one roof have made Roche
the leader in personalised healthcare - a strategy that aims to fit
the right treatment to each patient in the best way
possible.
Roche is the world's largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and diseases of the central nervous system.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management.
Founded in 1896, Roche continues to search for better ways to
prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to
improve patient access to medical innovations by working with
all relevant stakeholders. Thirty medicines developed by Roche are
included in the World Health Organization Model Lists of Essential
Medicines, among them life-saving antibiotics, antimalarials and
cancer medicines. Moreover, for the tenth consecutive year, Roche
has been recognised as the most sustainable company in the
Pharmaceuticals Industry by the Dow Jones Sustainability Indices
(DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in
over 100 countries and in 2018 employed about 94,000 people
worldwide. In 2018, Roche invested CHF 11 billion in R&D and
posted sales of CHF 56.8 billion. Genentech, in the United
States, is a wholly owned member of the Roche Group. Roche is the
majority shareholder in Chugai Pharmaceutical, Japan. For more
information, please visit www.roche.com.
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Roche Group Media Relations
Phone: +41 61 688 8888 / e-mail:
media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
Roche submits new drug application
to FDA for Venclexta plus Gazyva