SAN
DIEGO, Calif. and ZUG, Switzerland, Nov. 10,
2023 /PRNewswire/ -- Mirati Therapeutics,
Inc.® (NASDAQ: MRTX), a commercial stage biotechnology
company, today announced that following a re-examination procedure,
the Company has received a positive opinion from the European
Medicine Agency's (EMA) Committee for Medicinal Products for Human
Use (CHMP) on KRAZATI® (adagrasib) as a targeted
treatment option for adult patients with KRASG12C
-mutated advanced non-small cell lung cancer (NSCLC) and disease
progression after at least one prior systemic therapy.
"Today's positive opinion from the CHMP for KRAZATI marks an
important step on the path to providing access to a potentially
best-in-class therapeutic option to patients living with this
difficult-to-treat disease," Alan
Sandler, M.D., chief medical officer, Mirati Therapeutics,
Inc. "We look forward to approval from the European Commission and
the opportunity to positively impact the lives of eligible patients
living in the European Union."
"This is an important day for the oncology community as we step
closer to a new therapeutic option being available to patients
living with KRASG12C mutated NSCLC in the European
Union," said Martin Reck, MD, PhD,
Lung Clinic Grosshansdorf, Germany. "Every patient has a slightly
different case so as more options become available physicians will
better be able to tailor their treatment for each patient."
About KRAZATI® (adagrasib)
Mirati has risen to meet one of the most challenging mutations
in cancer research by developing KRAZATI, a highly selective and
potent oral small-molecule inhibitor of KRASG12C.
Intentionally designed to meet the challenge of
KRASG12C, adagrasib is optimized to sustain
target inhibition, an attribute that could be important to
treat KRASG12C-mutated cancers, as the
KRASG12C protein regenerates every 24−48
hours.1 Adagrasib has shown clinically to be a
CNS penetrant, which may be important given that CNS metastases
frequently occur in NSCLC and lead to poor
prognosis.2,3,4
The FDA provided KRAZATI Accelerated Approval (Subpart H),
allowing for the approval of drugs that treat serious conditions,
and that fill an unmet medical need based on surrogate endpoints.
KRAZATI was also granted a conditional marketing authorization by
the United Kingdom's Medicines and
Healthcare Products Regulatory Agency (MHRA) on November 3, 2023.
Adagrasib continues to be evaluated as monotherapy and in
combination with other anti-cancer therapies in patients with
advanced KRASG12C-mutated solid tumors, including
NSCLC, colorectal cancer, and pancreatic cancer. For more
information, visit Mirati.com/science.
About the KRYSTAL-1 Study
KRYSTAL-1 is an open-label Phase 1/2 multiple-expansion
cohort trial evaluating adagrasib as monotherapy
and in combination with other anti-cancer therapies in patients
with advanced solid tumors harboring
the KRASG12C mutation.
About KRASG12C in NSCLC
Lung cancer is one of the most common cancers worldwide,
accounting for 2.21 million new cases and 1.8 million deaths
worldwide in 2020.5 Lung cancer consists of NSCLC
in approximately 85% of cases and small cell lung cancer (SCLC) in
approximately 15% of cases.6 KRASG12C is
the most common KRAS mutation in NSCLC, present in
approximately 14% of patients with lung adenocarcinoma, and is a
biomarker mutation of poor prognosis.1,3
About Mirati Therapeutics, Inc.
Mirati Therapeutics, Inc. is a commercial stage biotechnology
company whose mission is to discover, design and deliver
breakthrough therapies to transform the lives of patients with
cancer and their loved ones. The company is relentlessly focused on
bringing forward therapies that address areas of high unmet need,
including lung cancer, and advancing a pipeline of novel
therapeutics targeting the genetic and immunological drivers of
cancer. Unified for patients, Mirati's vision is to unlock the
science behind the promise of a life beyond cancer.
For more information about Mirati, visit us
at Mirati.com or follow us on Twitter, LinkedIn, and
Facebook.
Forward Looking Statements
This press release includes forward-looking statements regarding
Mirati Therapeutic, Inc.'s ("Mirati") business, the therapeutic and
commercial potential of KRAZATI® (adagrasib), MRTX1719
(MTA-cooperative PRMT5 inhibitor), MRTX0902 (SOS1 inhibitor), and
MRTX1133 (selective KRASG12D inhibitor), and Mirati's technologies
and other products in development. Any statement describing
Mirati's goals, expectations, intentions or beliefs, financial or
other projections, is a forward-looking statement and should be
considered an at-risk statement. Such statements are subject to
certain risks and uncertainties, including those inherent in the
process of discovering, developing and commercializing medicines
that are safe and effective for use as human therapeutics, the
endeavor of building a business around such medicines, and the
proposed acquisition of Mirati by Bristol-Myers Squibb Company.
Mirati's forward-looking statements also involve assumptions
that, if they never materialize or prove correct, could cause its
results to differ materially from those expressed or implied by
such forward-looking statements. Although Mirati's forward-looking
statements reflect the good faith judgment of its management, these
statements are based only on facts and factors currently known by
Mirati. As a result, you are cautioned not to rely on these
forward-looking statements. These and other risks concerning
Mirati's programs are described in additional detail in Mirati's
annual report on Form 10-K, and most recent Form 10-Q, which are on
file with the Securities and Exchange Commission (the "SEC") and
available at the SEC's website (www.sec.gov). These forward-looking
statements are made as of the date of this press release, and
Mirati assumes no obligation to update the forward-looking
statements, or to update the reasons why actual results could
differ from those projected in the forward-looking statements,
except as required by law.
Mirati Contacts
Investor Relations: ir@mirati.com
Media Relations: media@mirati.com
References
1 Hallin J, Engstrom LD, Hargis L, et al. The
KRASG12C Inhibitor MRTX849 Provides Insight toward
Therapeutic Susceptibility of KRAS-Mutant Cancers in Mouse Models
and Patients. Cancer Discov. 2020;10(1):54-71.
2 Sabari JK, Velcheti V, Shimizu K, et al.
Activity of Adagrasib (MRTX849) in Brain Metastases: Preclinical
Models and Clinical Data from Patients with KRASG12C-Mutant
Non-Small Cell Lung Cancer. Clin Cancer
Res. 2022;28(15):3318-3328.
3 Cagney DN, Martin AM, Catalano PJ, et al.
Incidence and prognosis of patients with brain metastases at
diagnosis of systemic malignancy: a population-based study.
Neuro Oncol. 2017;19(11):1511-1521.
4 Ali A, Goffin JR, Arnold A, Ellis PM. Survival
of patients with non-small-cell lung cancer after a diagnosis of
brain metastases. Curr Oncol. 2013;20(4):e300-6.
5 Lung cancer statistics. WCRF International.
https://www.wcrf.org/cancer-trends/lung-cancer-statistics/.
Published April 14, 2022.
6 Molina JR, Yang P, Cassivi SD, Schild SE,
Adjei AA. Non-small cell lung cancer: epidemiology, risk factors,
treatment, and survivorship. Mayo Clin
Proc. 2008;83(5):584-94.
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