Knight Therapeutics Inc. Announces Approval of Lenvima® in Colombia
04 Januar 2022 - 02:00PM
Knight Therapeutics Inc. (TSX:GUD) (“Knight” or “the Company”)
announced today that its Colombian affiliate, Biotoscana Farma S.A.
has obtained INVIMA approval for Lenvima® (lenvatinib), the orally
available multiple receptor tyrosine kinase inhibitor developed by
Eisai, for the treatment of radioiodine refractory differentiated
thyroid cancer (RR-DTC) and unresectable hepatocellular carcinoma
(u-HCC).
Lenvima® (lenvatinib) demonstrated a
statistically significant progression-free survival prolongation
and response rate in patients with progressive, differentiated
thyroid cancer who had become refractory to radioactive iodine
therapy1. In a separate study in patients with previously untreated
unresectable HCC2, Lenvima® (lenvatinib) was proven to be non
inferior to sorafenib for overall survival. In addition, Lenvima®
(lenvatinib) was statistically significantly superior to sorafenib
for progression-free survival and objective response rate. In 2020,
there were approximately 5,3043 new patients with thyroid cancer
and 2,2893 new patients with liver cancer in Colombia.
“We’re pleased to announce the approval of
Lenvima® (lenvatinib) in Colombia as it provides a new treatment
option for radioiodine refractory differentiated thyroid cancer and
unresectable hepatocellular carcinoma,” said Samira Sakhia,
President & Chief Executive Officer. “We look forward to
working with payors to ensure access to the product for all
patients who can benefit from Lenvima® (lenvatinib).”
Knight has an exclusive license from Eisai to
commercialize Lenvima® (lenvatinib), Halaven® (eribulin mesylate),
Fycompa® (perampanel) and Inovelon® (rufinamide) throughout Latin
America, with the exception of Mexico where Eisai retains the
rights to Halaven® (eribulin mesylate) and Lenvima®
(lenvatinib).
About LENVIMA® (lenvatinib); available as 10mg
and 4mg capsules
LENVIMA® (lenvatinib),
discovered and developed by Eisai, is a kinase inhibitor that
inhibits the kinase activities of vascular endothelial growth
factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3
(FLT4). LENVIMA® (lenvatinib) inhibits other
kinases that have been implicated in pathogenic angiogenesis, tumor
growth, and cancer progression in addition to their normal cellular
functions, including fibroblast growth factor (FGF) receptors
FGFR1-4, the platelet derived growth factor receptor alpha
(PDGFRα), KIT, and RET.
Currently, LENVIMA®
(lenvatinib) has been approved for monotherapy as a
treatment for thyroid cancer in over 75 countries including Japan,
in Europe, China and in Asia, and in the United States for locally
recurrent or metastatic, progressive, radioiodine-refractory
differentiated thyroid cancer. In addition,
LENVIMA® (lenvatinib) has been
approved for monotherapy as a treatment for unresectable
hepatocellular carcinoma in over 70 countries including Japan, in
Europe, China and in Asia, and in the United States for first-line
unresectable hepatocellular carcinoma. LENVIMA®
(lenvatinib) has been approved for monotherapy as a
treatment for unresectable thymic carcinoma in Japan. It has also
been approved in combination with everolimus as a treatment for
renal cell carcinoma following prior antiangiogenic therapy in over
60 countries, including in Europe and Asia, and in the United
States the treatment of adult patients with advanced renal cell
carcinoma following one prior anti-angiogenic therapy. In Europe,
the agent was launched under the brand name Kisplyx® for renal cell
carcinoma. LENVIMA® (lenvatinib) has been approved
in combination with KEYTRUDA® (generic name: pembrolizumab), for
the first-line treatment of adult patients with advanced renal cell
carcinoma (RCC) in the United States. LENVIMA®
(lenvatinib) has been approved in combination with
KEYTRUDA® (generic name: pembrolizumab) as a treatment for advanced
endometrial carcinoma that is not microsatellite instability-high
(MSI-H) or mismatch repair deficient (dMMR) who have disease
progression following prior systemic therapy in any setting and are
not candidates for curative surgery or radiation in the United
States, and has been approved for the similar indication (including
conditional approval) in over 10 countries such as Canada and
Australia. In some regions, continued approval for this indication
is contingent upon verification and description of clinical benefit
in the confirmatory trials.
About Knight Therapeutics Inc.
Knight Therapeutics Inc., headquartered in
Montreal, Canada, is a specialty pharmaceutical company focused on
acquiring or in-licensing and commercializing innovative
pharmaceutical products for Canada and Latin America. Knight owns
Biotoscana Investments S.A., a pan-Latin American specialty
pharmaceutical company. Knight’s Latin American subsidiaries
operate under United Medical, Biotoscana Farma and Laboratorio LKM.
Knight Therapeutics Inc.'s shares trade on TSX under the symbol
GUD. For more information about Knight Therapeutics Inc., please
visit the company's web site at www.gud-knight.com or
www.sedar.com.
Forward-Looking Statement
This document contains forward-looking
statements for Knight Therapeutics Inc. and its subsidiaries. These
forward-looking statements, by their nature, necessarily involve
risks and uncertainties that could cause actual results to differ
materially from those contemplated by the forward-looking
statements. Knight Therapeutics Inc. considers the assumptions on
which these forward-looking statements are based to be reasonable
at the time they were prepared but cautions the reader that these
assumptions regarding future events, many of which are beyond the
control of Knight Therapeutics Inc. and its subsidiaries, may
ultimately prove to be incorrect. Factors and risks, which could
cause actual results to differ materially from current expectations
are discussed in Knight Therapeutics Inc.'s Annual Report and in
Knight Therapeutics Inc.'s Annual Information Form for the year
ended December 31, 2020 as filed on www.sedar.com. Knight
Therapeutics Inc. disclaims any intention or obligation to update
or revise any forward-looking statements whether as a result of new
information or future events, except as required by law.
Investor Contact: |
|
Knight Therapeutics Inc. |
|
Samira Sakhia |
Arvind Utchanah |
President & Chief
Executive Officer |
Chief Financial Officer |
T: 514.484.4483 |
T. 514.484.4483 |
F: 514.481.4116 |
F. 514.481.4116 |
Email: info@knighttx.com |
Email: info@knighttx.com |
Website: www.gud-knight.com |
Website: www.gud-knight.com |
References:
- Schlumberger M, Tahara M, Wirth LJ et al. Lenvatinib versus
Placebo in Radioiodine Refractory Thyroid Cancer. N Engl J Med
2015;372(7):621-30.
- Kudo M, Finn RS, Qin S, et al. Lenvatinib vs sorafenib in
first-line treatment of patient with unresectable hepatocellular
carcinoma: a randomised, phase 3 non-inferiority trial. Lancet
2018. Doi: 10.1016/S0140-6736(18)30207-1.
- Cancer today. Gco.iarc.fr. (2021). Retrieved 14 September 2021,
from
https://gco.iarc.fr/today/online-analysis-table?v=2020&mode=cancer&mode_population=continents&population=900&populations=170&key=asr&sex=0&cancer=39&type=0&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1
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