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        • Today Bitcoin Price at $6,800 USD
        • Pandemic Is Changing BTC Usage in ‘Unexpected Ways’
        • Macropay on Alternative & local payment methods that are reshaping global e-commerce
        • Bank of America is preparing for a flood of Applications to Small-Business Loan
        • Microsoft might be the best tech stock in this market
        • US Airlines To Work Collectively, Consolidate Flights
        • Bank of America maintaining business continuity and protecting the bottom line
        • US long-term mortgage rates drop
        • Bitcoin Price Bulls have been rejected at $7,000
        • Stock Market: 4 Top Stock Trades for Wednesday: NVDA, AVGO, BAC, IQ
        • Stock Market April 2 – Edge Higher; Oil Surges, Bonds Fall, Dollar Rose
        • Chase bank will raise up to $10 billion
          • Bitcoin Price Simply Surged to $6,500 After Over 10% Weekend Crash
          • Today Bitcoin Price at $7,000: BTC Leaps to Retest $7,000
          • Bank of America agreed to allow 50,000 mortgage customers to defer payments
        • Bitcoin Price Prediction April: Three Key Causes Why BTC May Plunge Beneath $5,000
          • Roll up the Sleeves! American Airlines was down -10.34%
          • Mortgage calculator rates today April 2, 2020
          • Mortgage Calculator Small businesses: SB have ‘a million inquiries’ regarding check help loans
          • Bitcoin Price Today April 1 – Bitcoin Takes Tumble
            • With Bank of America card you can request a payment deferral online
              • Bank of America fields 150,000 installment deferral demands
            • Coronavirus – Travel Insurance no cover cancellations
              • Bank of America said it won’t cut any positions
          • Bitcoin Price Today April 2 – BTC rise to $6,700
          • Mortgage calculator rates today March 31, 2020
          • Bitcoin Price Momentum Sign Reverses, Bull Run Lastly Inbound?
          • Bitcoin Price Recovering After a Sharp Decline
          • Fintech News Airbnb – How hosts are fighting back against Covid-19 fallout
          • Market Stock Boeing – Challenging Times Ahead for Boeing Stock
        • Bank of America U.S. Minimum Hourly Wage Reaches $20
          • Bitcoin Price Bulls – is Forming a Bull Cross After Rallying to $6,500
          • P2P Crowdlending – Average Interest Rate 18%
          • $633 Million BTC Transferred For Simply $0.26 Payment
        • Prime ICO Advertising and marketing Companies
        • Bank of America will provide up to $250 million
        • Bank of America VC: You tend to do the wrong thing at the wrong time
          • Bitcoin Price Jump as Coronavirus Curve Begins to Flatten
            • Bitcoin Price Today April 3
            • Bitcoin Price Is Sometimes Bullish in Q2
            • Bitcoin Price Tumble Beneath $ 6,000
            • BTC Price Today 5 | April, 2020
            • Bitcoin Price and S&P 500 – Here’s how much bitcoin beat the Dow and S&P 500 in the first quarter
              • Today Bitcoin Price at $6,600
                • Bitcoin Price Bulls Reaches: “Live or Die”
                • BTC Price Today | 6 April 2020
          • Bank of America sees big year for Microsoft ahead
            • American Airlines coronavirus downgrade
              • Bitcoin Price Rejected $6,600
              • Bitcoin Price Trace It Will Fall to $ 5 K
              • BTC Price Today April 4
                • Stock Market Today 31 March, 2020
              • US Bank Raises $586M Against COVID-19
                • Bank of America’s Solid Liquidity to Help Covid-19 Crisis
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      • Mortgage Calculator – Students Benefits
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      • Mortgage Calculator Modification – What Is?
      • Mortgage Calculator Canada: Rates Are Rising
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        • Mortgage rates today, April 3, 2020 plus reviews
          • cmc currency details
            • cmc exchange details
              • Shortcodes
        • Microsoft Vulnerability: Hundreds of Microsoft Servers Contaminated By Crypto-Mining Botnet Since 2018
          • Cision PR Newswire
          • Coupons – Best websites
            • Aeromexico Rewards Chart
            • Get Avios Points Free
        • Today Bitcoin Price at $6,800 USD
        • Pandemic Is Changing BTC Usage in ‘Unexpected Ways’
        • Macropay on Alternative & local payment methods that are reshaping global e-commerce
        • Bank of America is preparing for a flood of Applications to Small-Business Loan
        • Microsoft might be the best tech stock in this market
        • US Airlines To Work Collectively, Consolidate Flights
        • Bank of America maintaining business continuity and protecting the bottom line
        • US long-term mortgage rates drop
        • Bitcoin Price Bulls have been rejected at $7,000
        • Stock Market: 4 Top Stock Trades for Wednesday: NVDA, AVGO, BAC, IQ
        • Stock Market April 2 – Edge Higher; Oil Surges, Bonds Fall, Dollar Rose
        • Chase bank will raise up to $10 billion
          • Bitcoin Price Simply Surged to $6,500 After Over 10% Weekend Crash
          • Today Bitcoin Price at $7,000: BTC Leaps to Retest $7,000
          • Bank of America agreed to allow 50,000 mortgage customers to defer payments
        • Bitcoin Price Prediction April: Three Key Causes Why BTC May Plunge Beneath $5,000
          • Roll up the Sleeves! American Airlines was down -10.34%
          • Mortgage calculator rates today April 2, 2020
          • Mortgage Calculator Small businesses: SB have ‘a million inquiries’ regarding check help loans
          • Bitcoin Price Today April 1 – Bitcoin Takes Tumble
            • With Bank of America card you can request a payment deferral online
              • Bank of America fields 150,000 installment deferral demands
            • Coronavirus – Travel Insurance no cover cancellations
              • Bank of America said it won’t cut any positions
          • Bitcoin Price Today April 2 – BTC rise to $6,700
          • Mortgage calculator rates today March 31, 2020
          • Bitcoin Price Momentum Sign Reverses, Bull Run Lastly Inbound?
          • Bitcoin Price Recovering After a Sharp Decline
          • Fintech News Airbnb – How hosts are fighting back against Covid-19 fallout
          • Market Stock Boeing – Challenging Times Ahead for Boeing Stock
        • Bank of America U.S. Minimum Hourly Wage Reaches $20
          • Bitcoin Price Bulls – is Forming a Bull Cross After Rallying to $6,500
          • P2P Crowdlending – Average Interest Rate 18%
          • $633 Million BTC Transferred For Simply $0.26 Payment
        • Prime ICO Advertising and marketing Companies
        • Bank of America will provide up to $250 million
        • Bank of America VC: You tend to do the wrong thing at the wrong time
          • Bitcoin Price Jump as Coronavirus Curve Begins to Flatten
            • Bitcoin Price Today April 3
            • Bitcoin Price Is Sometimes Bullish in Q2
            • Bitcoin Price Tumble Beneath $ 6,000
            • BTC Price Today 5 | April, 2020
            • Bitcoin Price and S&P 500 – Here’s how much bitcoin beat the Dow and S&P 500 in the first quarter
              • Today Bitcoin Price at $6,600
                • Bitcoin Price Bulls Reaches: “Live or Die”
                • BTC Price Today | 6 April 2020
          • Bank of America sees big year for Microsoft ahead
            • American Airlines coronavirus downgrade
              • Bitcoin Price Rejected $6,600
              • Bitcoin Price Trace It Will Fall to $ 5 K
              • BTC Price Today April 4
                • Stock Market Today 31 March, 2020
              • US Bank Raises $586M Against COVID-19
                • Bank of America’s Solid Liquidity to Help Covid-19 Crisis
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      • Best Online Savings Accounts of February 2020
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      • 6% cd rates – They Exists ?
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      • Best Credit Cards for Students 2020
      • Best Airline Credit Card 2020
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      • Best Rewards Credit Card 2020
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      • 11 Best Prepaid Debit Cards of 2020
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      • Lowe’s Credit Card
      • Get Revolut Card + £50
      • Qantas Credit Card
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      • How many credit cards should I have?
      • Is Discover Visa or Mastercard?
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      • Wells Fargo Propel – Review
      • Walmart Money Card – Review
      • Credit One Credit Card Review
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      • Travel credit card reviews 2020
      • Petal Credit Card Review
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      • Best Mortgage for Low Down Payment 2020
      • Best Mortgage Rates
      • Best VA Mortgage Lenders of 2020
      • Greatest On-line Mortgage Lenders
      • The Best Mortgage Lenders for First Time Home Buyers
    • Mortgage Calculators
      • Mortgage calculator rates today April 1, 2020
      • Mortgage Calculator – Students Benefits
      • Mortgage Calculator – Homeowners and renters Get Payment Relief
      • Calculator for mortgage to millennials
      • Mortgage Calculator Modification – What Is?
      • Mortgage Calculator Canada: Rates Are Rising
      • Mortgage Calculator Home – Is it time to repair your own home mortgage?
      • Mortgage Calculator
      • Mortgage Calculator Rates Today April 3
      • Mortgage Calculator Online
      • Mortgage Calculator Coronavirus: UK mortgage market goes into lockdown
    • Mortgage Guides
      • Lending
      • How Mortgage Forbearance Works Under CARES Act
      • Stimulus Check
    • Mortgage Companies
      • Nationstar Mortgage
      • Roundpoint Mortgage
      • Midland Mortgage
      • Simple Mortgage Calculator
      • Freedom Mortgage
      • SunTrust Mortgage
  • Commodities
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      • WTI Oil Prices
      • Brent Crude
      • Crude Oil
    • Agricultural Products
      • Corns
    • Livestock & Meat
      • Lean Hogs
    • Precious Metals
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      • Gold
        • Best Place to Buy Gold
        • Price of Gold
        • 5 Ways In order to Buy Gold
        • Gold Price Chart
        • Gold Futures
      • Silver
    • Industrial Metals
      • Copper
  • Insurtech
    • Insurtech “Best of…”
      • Best Life Insurance of 2020
      • The Best Renters Insurance Companies 2020
      • Best Pet Insurance Providers of 2020
      • Best Home Insurance Companies for 2020
      • Best Car Insurance Quotes Online
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Amgen – Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China

Judie Simms by Judie Simms
January 29, 2021
in Amgen
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Home » Amgen – Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China

Amgen – Amgen Announces Breakthrough Therapy Designation Granted For Sotorasib In China

THOUSAND OAKS, Calif., Jan. 29, 2021 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that its investigational KRASG12C inhibitor sotorasib was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation is for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. This is the first BTD submission for Amgen in China, as well as the first under Amgen’s strategic collaboration with BeiGene. 

NSCLC is the most common form of lung cancer, accounting for approximately 80-85% of all cases worldwide.1 KRAS G12C is the most common KRAS mutation in NSCLC.2,3 The mutation is a biomarker of poor prognosis in Chinese NSCLC patients, which may be improved by G12C-specific inhibitors.4 Research has shown that about 3-5% have the KRAS G12C mutation – found most commonly in smokers.4,5

“Given that Breakthrough Therapy Designation is a new pathway in China, we are pleased to receive this designation for sotorasib,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “This designation underscores the importance of sotorasib and we look forward to working with regulatory authorities in China to bring the first potential targeted therapy to NSCLC patients with the KRAS G12C mutation.”

The Breakthrough Therapy Designation is supported by the positive CodeBreaK 100 Phase 2 results in patients with advanced NSCLC whose cancer had progressed despite prior treatment with chemotherapy and/or immunotherapy. In the study, treatment with sotorasib demonstrated durable anticancer activity with a positive benefit-risk profile.6 These results will be presented at the International Association for the Study of Lung Cancer (IASLC) 2020 World Conference on Lung Cancer (WCLC) Presidential Symposium from 3:50-4 p.m. PST on Friday, Jan. 29.

The NMPA’s BTD process is designed to expedite the development and review of therapies that are intended for the prevention or treatment of serious life-threatening diseases for which there is no existing treatment and where preliminary evidence indicates advantages of the therapy over available treatment options.7 This designation shows the potential for sotorasib to become the first targeted treatment available in China for KRAS G12C-mutated NSCLC.

Amgen has taken on one of the toughest challenges of the last 40 years in cancer research by developing sotorasib, the first KRASG12C inhibitor to enter the clinic.8 Sotorasib is being studied in the broadest clinical program exploring 10 combinations with global sites spanning across four continents. In just over two years, the sotorasib clinical trial program has also established the deepest clinical data set with nearly 700 patients studied across 13 tumor types.

About CodeBreaK
The CodeBreaK clinical development program for Amgen’s investigational drug sotorasib is designed to treat patients with an advanced solid tumor with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled nearly 700 patients across 13 tumor types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer is fully enrolled and topline results are expected in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) is currently recruiting. Amgen also has more than 10 Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101) open for enrollment.

For information, please visit www.codebreaktrials.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit AmgenOncology.com. For more information, follow us on www.twitter.com/amgenoncology.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration’s, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

Contacts: Amgen, Thousand Oaks
Trish Rowland, 805-447-5631 (Media)
Jessica Akopyan, 805-447-0974 (Media)
Arvind Sood, 805-447-1060 (Investors)

References

1 American Cancer Society. Available at https://www.cancer.org/cancer/lung-cancer/about/what-is.html#:~:text=About%2080%25%20to%2085%25%20of,(outlook)%20are%20often%20similar. Accessed January 2021.
2 Pakkala S, et al. JCI Insight. 2018;3:e120858. 
3 Arbour KC, et al. Clin Cancer Res. 2018;24:334-340. 
4 Liu S, et al. Clinical characteristics and prognostic value of the KRAS G12C mutation in Chinese non-small cell lung cancer patients. Biomark Res 8, 22 (2020). https://doi.org/10.1186/s40364-020-00199-z.
5 Loong, et al. Transl Lung Cancer Res. 2020 Oct; 9(5): 1759–1769.
6 AMGEN, 2020. Retrieved January 20, 2021, from https://www.amgen.com/newsroom/press-releases/2020/10/amgen-announces-positive-topline-phase-2-results-for-investigational-kras-g12c-inhibitor-sotorasib-in-advanced-non-small-cell-lung-cancer.
7 China Drug Registration Regulation: http://www.gov.cn/gongbao/content/2020/content_5512563.htm
8
 Kim D, et al. Cell. 2020. doi:10.1016/j.cell.2020.09.044.

SOURCE Amgen

Related Links

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