- Tivozanib assigned PDUFA target action date
of March 31, 2021; FDA indicates that it does not currently plan to
convene an ODAC -
AVEO Oncology (NASDAQ: AVEO) today announced that the U.S. Food
and Drug Administration (FDA) accepted for filing its New Drug
Application (NDA) seeking approval for tivozanib, the Company’s
next-generation vascular endothelial growth factor receptor
tyrosine kinase inhibitor (VEGFR-TKI), as a treatment for relapsed
or refractory renal cell carcinoma (RCC). The FDA has assigned the
application standard review and a Prescription Drug User Fee Act
target action date of March 31, 2021. The FDA also indicated that
they do not currently plan on convening an Oncologic Drug Advisory
Committee (ODAC) to discuss the application.
“The acceptance of our NDA filing marks yet another important
milestone for AVEO, as we pursue our goal of providing RCC patients
whose disease has relapsed or become refractory to multiple lines
of therapy with a meaningful new treatment option,” said Michael
Bailey, president and chief executive officer. “We look forward to
working closely with the FDA over the coming months during their
review of our application. In parallel, we continue to focus on
commercial-readiness to ensure we are well positioned to support
the potential launch of tivozanib, subject to approval.”
The NDA submission is based on AVEO’s pivotal Phase 3 study,
TIVO-3, comparing tivozanib to sorafenib in 3rd and 4th line RCC,
including results recently presented at the American Society of
Clinical Oncology 2020 Virtual Scientific Program. The application
is also supported by three additional trials, including an active
comparator-controlled Phase 3 study, TIVO-1, comparing tivozanib to
sorafenib in first line RCC, and two Phase 2 studies, Study 902,
the open-label, crossover clinical study of tivozanib for patients
who progressed on sorafenib in TIVO-1, as well as
placebo-controlled Study 201 in first line RCC. In total, data from
over 1,000 clinical trial subjects support the application.
About Tivozanib (FOTIVDA®)
Tivozanib (FOTIVDA®) is an oral, once-daily, next-generation
vascular endothelial growth factor receptor (VEGFR) tyrosine kinase
inhibitor (TKI) discovered by Kyowa Kirin and approved for the
treatment of adult patients with advanced renal cell carcinoma
(RCC) in the European Union, the United Kingdom, Norway, New
Zealand and Iceland. It is a potent, selective and long half-life
inhibitor of all three VEGF receptors and is designed to optimize
VEGF blockade while minimizing off-target toxicities, potentially
resulting in improved efficacy and minimal dose modifications.1,2
Tivozanib is being studied in the TIVO-3 trial, which is supporting
a regulatory submission of tivozanib in the U.S. seeking marketing
approval as a treatment for relapsed or refractory RCC. Tivozanib
has been shown to significantly reduce regulatory T-cell production
in preclinical models3 and has demonstrated synergy in combination
with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib
has been investigated in several tumor types, including renal cell,
hepatocellular, colorectal, ovarian and breast cancers.
About AVEO
AVEO is developing an oncology pipeline designed to provide a
better life for patients with cancer. AVEO’s strategy is to focus
its resources toward development and commercialization of its
product candidates in North America, while leveraging partnerships
to support development and commercialization in other geographies.
AVEO’s lead candidate, tivozanib (FOTIVDA®) is approved in the
European Union, the United Kingdom, Norway, New Zealand and Iceland
for the treatment of adult patients with advanced renal cell
carcinoma. AVEO is working to develop and commercialize tivozanib
in North America as a treatment for renal cell carcinoma,
hepatocellular carcinoma and other cancers. Ficlatuzumab (HGF MAb)
is in a Phase 2 clinical trial in head and neck cancer and has
reported early clinical data in pancreatic cancer. AVEO’s
earlier-stage pipeline includes several monoclonal antibodies in
oncology development, including AV-203 (anti-ErbB3 MAb), AV-380
(GDF15 MAb) and AV-353 (Notch 3 MAb). For more information, please
visit the Company’s website at www.aveooncology.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of AVEO
within the meaning of the Private Securities Litigation Reform Act
of 1995 that involve substantial risks and uncertainties. All
statements, other than statements of historical fact, contained in
this press release are forward-looking statements. The words
“anticipate,” “believe,” “expect,” “hope,” “intend,” “may,” “plan,”
“potential,” “could,” “should,” “would,” “seek,” “look forward,”
“advance,” “goal,” “strategy,” or the negative of these terms or
other similar expressions, are intended to identify forward-looking
statements, although not all forward-looking statements contain
these identifying words. These forward-looking statements include,
among others, statements about: the potential for tivozanib as a
treatment option for patients with advanced HCC or
relapsed/refractory or advanced RCC, and following earlier TKI and
immunotherapy treatment; the potential efficacy, safety, and
tolerability of tivozanib, both as a stand-alone drug candidate and
in combination with other therapies in several indications; AVEO’s
execution of its clinical and regulatory strategy for tivozanib;
AVEO’s plans and strategies for commercialization of tivozanib in
the United States and Europe; and AVEO’s strategy, prospects, plans
and objectives for its product candidates and for the Company
generally. AVEO has based its expectations and estimates on
assumptions that may prove to be incorrect. As a result, readers
are cautioned not to place undue reliance on these expectations and
estimates. Actual results or events could differ materially from
the plans, intentions and expectations disclosed in the
forward-looking statements that AVEO makes due to a number of
important factors, including risks relating to: whether the results
of TIVO-3 are sufficient to obtain marketing approval for tivozanib
in the U.S., which turns on the ability of AVEO to demonstrate to
the satisfaction of the FDA the safety and efficacy of tivozanib
based upon the findings of TIVO-3, including its data with respect
to PFS, the rate of adverse events, OS and other information that
the FDA may determine to be relevant to approvability; AVEO’s
ability, and the ability of its licensees, to demonstrate to the
satisfaction of applicable regulatory agencies such as the FDA the
safety, efficacy and clinically meaningful benefit of AVEO’s
product candidates; and AVEO’s ability to enter into and maintain
its third party collaboration and license agreements, and its
ability, and the ability of its strategic partners, to achieve
development and commercialization objectives under these
arrangements. AVEO faces other risks relating to its business as
well, including risks relating to the timing and costs of seeking
and obtaining regulatory approval; AVEO’s and its collaborators’
ability to successfully enroll and complete clinical trials; AVEO’s
ability to maintain compliance with regulatory requirements
applicable to its product candidates; AVEO’s ability to obtain and
maintain adequate protection for intellectual property rights
relating to its product candidates; AVEO’s ability to successfully
implement its strategic plans, including its ability to
successfully launch and commercialize tivozanib if it may be
approved for commercialization by the FDA; AVEO’s ability to raise
the substantial additional funds required to achieve its goals,
including those goals pertaining to the development and
commercialization of tivozanib; unplanned capital requirements;
adverse general economic and industry conditions; the potential
adverse effects of the COVID-19 pandemic on AVEO’s business
continuity, financial condition, results of operations, liquidity
and ability to successfully and timely enroll, complete and
read-out data from its clinical trials; competitive factors; and
those risks discussed in the sections titled “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations—Liquidity and Capital Resources” included in
AVEO’s quarterly and annual reports on file with the Securities and
Exchange Commission (SEC) and in other filings that AVEO makes with
the SEC. The forward-looking statements in this press release
represent AVEO’s views as of the date of this press release, and
subsequent events and developments may cause its views to change.
While AVEO may elect to update these forward-looking statements at
some point in the future, it specifically disclaims any obligation
to do so. You should, therefore, not rely on these forward-looking
statements as representing AVEO's views as of any date other than
the date of this press release.
Any reference to AVEO’s website address in this press release is
intended to be an inactive textual reference only and not an active
hyperlink.
References
- Fotivda (Tivozanib) SmPC August 2017
- Motzer RJ, Nosov D, Eisen T, et al. J Clin Oncol 2013; 31(30):
3791-9
- Pawlowski N et al. AACR 2013. Poster 3971
- Barthelemy et al. ESMO 2018. Poster 878P
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200601005605/en/
AVEO Contact: David Pitts, Argot Partners (212) 600-1902
aveo@argotpartners.com
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