SAN
DIEGO and ZUG, Switzerland, Nov. 3, 2023
/PRNewswire/ -- Mirati Therapeutics, Inc. (NASDAQ: MRTX), a
commercial stage biotechnology company, today announced the
United Kingdom's Medicines and
Healthcare Products Regulatory Agency (MHRA) granted conditional
marketing authorization approval for KRAZATI® (adagrasib) as
a monotherapy indicated for the treatment of adult patients with
advanced non-small cell lung cancer (NSCLC) with
KRASG12C mutation and have progressive disease after
prior therapy with, or intolerance to, platinum-based chemotherapy
and/or anti-PD-1/PD-L1 immunotherapy.
"KRAZATI offers a compelling therapeutic option for patients
with previously treated locally advanced NSCLC with a
KRASG12C mutation. MHRA's authorization is a significant
step towards improving the options available for patients and
clinicians in Great Britain," said
Alan Sandler, M.D., chief medical
officer, Mirati Therapeutics, Inc. "We are encouraged by the
opportunity to bring KRAZATI, a potential best-in-class treatment
to qualified patients."
"Fourteen percent of people living with NSCLC harbour the
KRASG12C mutation yet there are limited targeted
treatment options for patients with this devastating
disease1,2," said Dr Shobhit
Baijal (Consultant Medical Oncologist of The University
Hospital Birmingham). "The expansion of treatment options
for NSCLC benefits patients and clinicians alike. As
someone intensively involved in the management of lung cancer
patients, I look forward to KRAZATI being available for use in
clinical practice."
For more information, visit KRAZATI.com.
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
KRAZATI (adagrasib) GB Indication
KRAZATI as monotherapy is indicated for the treatment of adult
patients with advanced non-small cell lung cancer (NSCLC) with KRAS
G12C mutation and have progressive disease after prior therapy
with, or intolerance to, platinum-based chemotherapy and/or
anti-PD-1/PD-L1 immunotherapy.
Important Safety Information
The full Summary of Product Characteristics (SPC/SmPC) for
KRAZATI® (adagrasib) will be available on the MHRA
website at https://products.mhra.gov.uk/.
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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