FDA Defers Action on BLA Until Required
Inspections Can Be Completed
Due to COVID Travel Restrictions, Inspections
Could Not Be Completed During Review Period
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global
oncology biotechnology company focused on developing innovative and
affordable medicines to improve treatment outcomes and access for
patients worldwide, today announced that the U.S. Food and Drug
Administration (FDA) has deferred action on the Biologics License
Application (BLA) for tislelizumab as a second-line (2L) treatment
for patients with unresectable or metastatic esophageal squamous
cell carcinoma (ESCC). The FDA has been unable to conduct required
inspections in China due to COVID-19 related travel restrictions.
As a result, the FDA is deferring action on the application until
the inspections are complete.
In the letter, the FDA cited only travel restrictions and the
inability to complete inspections as the reason for the deferral.
The application remains under review, and the FDA did not provide a
new anticipated action date as they continue to monitor the public
health situation and travel restrictions. BeiGene and Novartis will
continue to work actively with the FDA to support scheduling the
required inspections as soon as possible.
“We are working with our partner, Novartis, to facilitate the
required inspections and bring tislelizumab to patients with
second-line esophageal cancer in the U.S. following regulatory
approval,” said John V. Oyler, Co-Founder, Chairman and CEO of
BeiGene.
In September 2021, the FDA accepted the BLA for tislelizumab in
2L ESCC and provided a Prescription Drug User Fee Act (PDUFA) goal
date of July 12, 2022. The evidence base for the BLA submission
includes results from RATIONALE 302, a randomized, open-label,
multi-regional Phase 3 trial that enrolled 512 patients from
Europe, U.S. and Asia and safety data on 1,972 patients who
received tislelizumab as a monotherapy from seven clinical trials.
The RATIONALE 302 trial demonstrated a 30% reduction in the risk of
death (HR=0.70, 95% CI: 0.57-0.85, p=0.0001) and extended median
overall survival by 2.3 months compared to chemotherapy in people
with unresectable recurrent locally advanced or metastatic ESCC who
had received prior systemic therapy. Study results were published
in Journal of Clinical Oncology in May 2022.i
About Tislelizumab Tislelizumab is a humanized IgG4
anti-PD-1 monoclonal antibody specifically designed to minimize
binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid
the body’s immune cells to detect and fight tumors. In pre-clinical
studies, binding to Fcγ receptors on macrophages has been shown to
compromise the anti-tumor activity of PD-1 antibodies through
activation of antibody-dependent macrophage-mediated killing of T
effector cells.
Tislelizumab is the first drug from BeiGene’s immuno-oncology
biologics program and is being developed internationally as a
monotherapy and in combination with other therapies for the
treatment of a broad array of both solid tumor and hematologic
cancers.
The global tislelizumab clinical development program includes
more than 9,000 subjects enrolled to-date in more than 35 countries
and regions. BeiGene has initiated or completed more than 20
potentially registration-enabling clinical trials, including 17
Phase 3 trials. More information on the clinical trial program for
tislelizumab can be found here.
BeiGene Oncology BeiGene is committed to advancing best-
and first-in-class clinical candidates internally or with
like-minded partners to develop impactful and affordable medicines
for patients across the globe. We have a growing R&D and
medical affairs team of approximately 2,900 colleagues dedicated to
advancing more than 100 clinical trials that have involved more
than 16,000 subjects. Our expansive portfolio is directed
predominantly by our internal colleagues supporting clinical trials
in more than 45 countries and regions. Hematology-oncology and
solid tumor targeted therapies and immuno-oncology are key focus
areas for the Company, with both mono- and combination therapies
prioritized in our research and development. BeiGene currently has
three approved medicines discovered and developed in our own labs:
BTK inhibitor BRUKINSA® in the U.S., China, the European Union,
Great Britain, Canada, Australia, and additional international
markets; and the non-FC-gamma receptor binding anti-PD-1 antibody,
tislelizumab, as well as the PARP inhibitor, pamiparib, in
China.
BeiGene also partners with innovative companies who share our
goal of developing therapies to address global health needs. We
commercialize a range of oncology medicines in China licensed from
Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also
plan to address greater areas of unmet need globally through our
other collaborations including with Mirati Therapeutics, Seagen,
and Zymeworks.
In January 2021, BeiGene and Novartis announced a collaboration
granting Novartis rights to co-develop, manufacture, and
commercialize BeiGene’s anti-PD1 antibody, tislelizumab, in North
America, Europe, and Japan. Building upon this productive
collaboration, BeiGene and Novartis announced an option,
collaboration, and license agreement in December 2021 for BeiGene’s
TIGIT inhibitor, ociperlimab, that is in Phase 3 development.
Novartis and BeiGene also entered into a strategic commercial
agreement through which BeiGene will promote five approved Novartis
Oncology products across designated regions of China.
About BeiGene BeiGene is a global, science-driven
biotechnology company focused on developing innovative and
affordable medicines to improve treatment outcomes and access for
patients worldwide. With a broad portfolio of more than 40 clinical
candidates, we are expediting development of our diverse pipeline
of novel therapeutics through our own capabilities and
collaborations. We are committed to radically improving access to
medicines for two billion more people by 2030. BeiGene has a
growing global team of over 8,000 colleagues across five
continents. To learn more about BeiGene, please visit
www.beigene.com and follow us on Twitter at @BeiGeneGlobal.
Forward-Looking Statements This press release contains
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and other federal
securities laws, including statements regarding the potential for
tislelizumab to treat patients with 2L ESCC, the expected timing
for FDA onsite inspections, review and potential approval of the
BLA for tislelizumab in 2L ESCC, plans to make tislelizumab
available to patients with 2L ESCC following approval, BeiGene's
advancement of anticipated clinical development, regulatory
milestones and commercialization of tislelizumab, and BeiGene’s
plans, commitments, aspirations and goals under the headings
“BeiGene Oncology” and “About BeiGene.” Actual results may differ
materially from those indicated in the forward-looking statements
as a result of various important factors, including BeiGene's
ability to demonstrate the efficacy and safety of its drug
candidates; the clinical results for its drug candidates, which may
not support further development or marketing approval; actions of
regulatory agencies, which may affect the initiation, timing and
progress of clinical trials and marketing approval; BeiGene's
ability to achieve commercial success for its marketed medicines
and drug candidates, if approved; BeiGene's ability to obtain and
maintain protection of intellectual property for its medicines and
technology; BeiGene's reliance on third parties to conduct drug
development, manufacturing and other services; BeiGene’s limited
experience in obtaining regulatory approvals and commercializing
pharmaceutical products and its ability to obtain additional
funding for operations and to complete the development of its drug
candidates and achieve and maintain profitability; and the impact
of the COVID-19 pandemic on BeiGene’s clinical development,
regulatory, commercial, manufacturing, and other operations, as
well as those risks more fully discussed in the section entitled
“Risk Factors” in BeiGene’s most recent quarterly report on Form
10-Q, as well as discussions of potential risks, uncertainties, and
other important factors in BeiGene's subsequent filings with the
U.S. Securities and Exchange Commission. All information in this
press release is as of the date of this press release, and BeiGene
undertakes no duty to update such information unless required by
law.
_________________________________________ i DOI:
10.1200/JCO.21.01926 Journal of Clinical Oncology
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version on businesswire.com: https://www.businesswire.com/news/home/20220714005202/en/
Investors: Kevin Mannix +1 240-410-0129
ir@beigene.com
Media: Emily Collins + 201-201-4570 media@beigene.com
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