Log in
E-mail
Password
Show password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
New member
Sign up for FREE
New customer
Discover our services
Settings
Settings
Dynamic quotes 
OFFON
  1. Homepage
  2. Equities
  3. Japan
  4. Japan Exchange
  5. Chugai Pharmaceutical Co., Ltd
  6. News
  7. Summary
    4519   JP3519400000

CHUGAI PHARMACEUTICAL CO., LTD

(4519)
  Report
SummaryQuotesChartsNewsRatingsCalendarCompanyFinancialsConsensusRevisions 
SummaryMost relevantAll NewsAnalyst Reco.Other languagesPress ReleasesOfficial PublicationsSector newsMarketScreener Strategies

Chugai Pharmaceutical : Obtains Regulatory Approval for FoundationOne CDx Cancer Genomic Profile to Identify TMB-High Tumors

11/16/2021 | 01:16am EST

Chugai Obtains Regulatory Approval for FoundationOne CDx Cancer

Genomic Profile to Identify TMB-High Tumors

TOKYO, November 16, 2021 --Chugai Pharmaceutical Co., Ltd.(TOKYO: 4519) announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on November 15, 2021, for FoundationOne® CDx Cancer Genomic Profile to be used to identify advanced/recurrent tumor mutation burden-high(TMB-High; ≥10 mutations/megabase (mut/Mb)) solid tumors. An application for a humanized anti-humanPD-1 monoclonal antibody, pembrolizumab (genetical recombination) [Product name: Keytruda®] in TMB-High solid tumors that have progressed following prior chemotherapy was submitted by MSD K.K. on March 11, 2021 and is currently under review with the MHLW.

"The approval may enable physicians to make treatment suggestions based on TMB measurement. TMB is the third tumor-agnostic biomarker following NTRK fusion and high microsatellite instability," said Dr. Osamu Okuda, Chugai's President and CEO. "We will continue to encourage the proper use of this test to support treatment decision-making, and therefore enable better access to targeted therapies by evaluating many potential gene alterations at one time."

With this approval, FoundationOne CDx Cancer Genomic Profile will help identify patients with TMB- High advanced/recurrent solid tumors.

As a leading company in the field of oncology, Chugai is committed to realizing advanced personalized oncology care, and contributing to patients and healthcare professionals through improving access to comprehensive genomic profiling of cancers.

Approval information (underlined indicates newly added)

Intended uses or indications

  • The Product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers.
  • The Product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below.

Alterations

Cancer type

Relevant drugs

Activated EGFR alterations

Non-small cell lung

afatinib dimaleate, erlotinib

cancer (NSCLC)

hydrochloride, gefitinib,

osimertinib mesylate

EGFR exon 20 T790M

osimertinib mesylate

alterations

ALK fusion genes

alectinib hydrochloride,

crizotinib, ceritinib

ROS1 fusion genes

entrectinib

MET exon 14 skipping

capmatinib hydrochloride

alterations

hydrate

BRAF V600E and V600K

Malignant

dabrafenib mesylate,

alterations

melanoma

trametinib dimethyl sulfoxide,

vemurafenib

ERBB2 copy number alterations

Breast cancer

trastuzumab (genetical

(HER2 gene amplification

recombination)

positive)

KRAS/NRAS wild-type

Colorectal cancer

cetuximab (genetical

recombination), panitumumab

(genetical recombination)

Microsatellite instability high

nivolumab (genetical

recombination)

Microsatellite instability high

Solid tumors

pembrolizumab (genetical

recombination)

Tumor mutational burden-high

pembrolizumab (genetical

recombination)*

NTRK1/2/3 fusion gene

entrectinib, larotrectinib sulfate

BRCA1/2 alterations

Ovarian cancer

olaparib

BRCA1/2 alterations

Prostate cancer

olaparib

FGFR2 fusion genes

Biliary tract cancer

pemigatinib

* Application under review and not yet approved for the drug indication as of November, 2021

About FoundationOne CDx Cancer Genomic Profile

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next- generation sequencing based in vitro companion diagnostic device for the detection of substitutions,

2 / 3

insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed,paraffin-embedded (FFPE) tumor tissue specimens. The device is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

About tumor mutational burden

Tumor mutational burden (TMB) is a measure of the number of somatic mutations per coding region within a tumor's genome. Levels are measured by the number of non-inherited mutations occurring per megabase (1 million DNA base pairs) of the tumor genome, and with a status of 10 mutations per megabase or more defined as TMB-High by the FoundationOne CDx Cancer Genomic Profile. More neoantigen is induced in TMB-High tumors, and such tumors may respond better to immune-checkpoint inhibitors. TMB-High tumors are reported to be relatively common in malignant melanoma, non-small cell lung cancer, colorectal cancer, and endometrial cancer1).

Trademarks used or mentioned in this release are protected by laws.

[Reference]

1. Vanderwalde, A. et al.: Microsatellite instability status determined by next-generation sequencing and

compared with PD-L1 and tumor mutational burden in 11,348 patients. Cancer Med. 7(3): 746-756, 2018

###

3 / 3

Disclaimer

Chugai Pharmaceutical Co. Ltd. published this content on 16 November 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 November 2021 06:15:10 UTC.


© Publicnow 2021
All news about CHUGAI PHARMACEUTICAL CO., LTD
01/21CHUGAI PHARMACEUTICAL : Actemra Approved for Additional Indication of SARS-CoV-2 Pneumonia..
PU
2021CHUGAI PHARMACEUTICAL CO., LTD. : Ex-dividend day for final dividend
FA
2021CHUGAI PHARMACEUTICAL : Signs Joint Research Agreement with NCC for Asian International Co..
PU
2021Launch of Chugai's New TV Commercial 'Protect the Ordinary Days People Cherish' Featuri..
AQ
2021CHUGAI PHARMACEUTICAL : Anti-CD20 Monoclonal Antibody Rituxan Approved for Additional Indi..
PU
2021CHUGAI PHARMACEUTICAL : Launch of Chugai's New TV Commercial “Protect the Ordinary D..
PU
2021Chugai Pharmaceutical Co., Ltd. - Notice of Board of Director's Resolution on Applicati..
AQ
2021Chugai Obtained Highest A-Rating by CDP in Two Categories and SBT Validation for Greenh..
AQ
2021Chugai Pharmaceutical Co. - Update on the Development of Oral COVID-19 Drug Candidate A..
AQ
2021Nikkei 225 Declines 1.8% on Central Bank Outlooks
MT
More news
Analyst Recommendations on CHUGAI PHARMACEUTICAL CO., LTD
More recommendations
Financials
Sales 2021 975 B 8 577 M 8 577 M
Net income 2021 292 B 2 569 M 2 569 M
Net cash 2021 461 B 4 056 M 4 056 M
P/E ratio 2021 20,7x
Yield 2021 1,87%
Capitalization 6 051 B 53 179 M 53 211 M
EV / Sales 2021 5,73x
EV / Sales 2022 5,37x
Nbr of Employees 7 555
Free-Float -
Chart CHUGAI PHARMACEUTICAL CO., LTD
Duration : Period :
Chugai Pharmaceutical Co., Ltd Technical Analysis Chart | MarketScreener
Full-screen chart
Technical analysis trends CHUGAI PHARMACEUTICAL CO., LTD
Short TermMid-TermLong Term
TrendsNeutralBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 12
Last Close Price 3 680,00 JPY
Average target price 4 823,85 JPY
Spread / Average Target 31,1%
EPS Revisions
Managers and Directors
Tatsuro Kosaka Manager-Pharmaceutical Business Strategy Office
Osamu Okuda Manager-Life Cycle Management II
Itagaki Toshiaki CFO, Manager-Information Technology & Accounting
Hisafumi Okabe Senior Executive Officer & Head-Research
Junichi Nezu Executive Officer, GM-Research & Development
Sector and Competitors
1st jan.Capi. (M$)
CHUGAI PHARMACEUTICAL CO., LTD-1.47%53 179
JOHNSON & JOHNSON-3.40%434 036
ROCHE HOLDING AG-4.87%319 830
PFIZER, INC.-10.60%296 303
ABBVIE INC.-2.53%233 325
ELI LILLY AND COMPANY-11.98%220 356