* . *
  • About
  • Advertise
  • Privacy & Policy
  • Contact
Friday, September 5, 2025
Earth-News
  • Home
  • Business
  • Entertainment
    ITV Studios Launches New Entertainment Label – Global Bulletin – IMDb

    ITV Studios Unveils Exciting New Entertainment Label

    TS Entertainment bringing Malibu Jack’s to former Owensboro mall – Lane Report

    TS Entertainment Launches Malibu Jack’s at Former Owensboro Mall Location

    Jenny Han Dropped a Major ‘The Summer I Turned Pretty’ Easter Egg Revealing [SPOILER] – yahoo.com

    Jenny Han Just Unveiled a Huge ‘The Summer I Turned Pretty’ Easter Egg That Changes Everything [SPOILER]

    Liam Payne’s Cousin Ross Harris Honors Late Singer With Emotional Song ‘Bones’ – yahoo.com

    Liam Payne’s Cousin Ross Harris Honors Late Singer with Emotional New Song ‘Bones

    Country music star apologizes after drunken show ends with cops taking him down: ‘I’m not OK’ – PennLive.com

    Country Music Star Apologizes After Drunken Show Ends in Police Intervention: ‘I’m Not OK

    Comanche Nation Entertainment closes casino near Devol – KSWO 7News

    Comanche Nation Entertainment Closes Casino Near Devol in Surprising Move

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Gene Associated With Deadly Heart Disease in Golden Retrievers Identified – Technology Networks

    Breakthrough Discovery Uncovers Gene Behind Deadly Heart Disease in Golden Retrievers

    Monkey Island LNG Picks ConocoPhillips’ Liquefaction Technology – Hart Energy

    Monkey Island LNG Selects ConocoPhillips’ Advanced Liquefaction Technology for Next-Gen Energy Solutions

    Credo Technology Group Holding Ltd. (CRDO) Surpasses Q1 Earnings and Revenue Estimates – Yahoo Finance

    Credo Technology Group Surpasses Q1 Earnings and Revenue Expectations

    The Economist is hiring a science and technology correspondent – The Economist

    Exciting Opportunity: Become Our Next Science and Technology Correspondent!

    Blockchain lender Figure Technology seeks to raise up to $526M in IPO (FIGR:Pending) – Seeking Alpha

    Blockchain Lender Figure Technology Sets Sights on $526M in Thrilling IPO Launch

    New Technology from Ramsey Theory Group Brings Diagnostic Testing and Telehealth Directly into Patients’ Homes – Yahoo Finance

    Revolutionary Ramsey Theory Technology Delivers Diagnostic Testing and Telehealth Right to Your Doorstep

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
  • Home
  • Business
  • Entertainment
    ITV Studios Launches New Entertainment Label – Global Bulletin – IMDb

    ITV Studios Unveils Exciting New Entertainment Label

    TS Entertainment bringing Malibu Jack’s to former Owensboro mall – Lane Report

    TS Entertainment Launches Malibu Jack’s at Former Owensboro Mall Location

    Jenny Han Dropped a Major ‘The Summer I Turned Pretty’ Easter Egg Revealing [SPOILER] – yahoo.com

    Jenny Han Just Unveiled a Huge ‘The Summer I Turned Pretty’ Easter Egg That Changes Everything [SPOILER]

    Liam Payne’s Cousin Ross Harris Honors Late Singer With Emotional Song ‘Bones’ – yahoo.com

    Liam Payne’s Cousin Ross Harris Honors Late Singer with Emotional New Song ‘Bones

    Country music star apologizes after drunken show ends with cops taking him down: ‘I’m not OK’ – PennLive.com

    Country Music Star Apologizes After Drunken Show Ends in Police Intervention: ‘I’m Not OK

    Comanche Nation Entertainment closes casino near Devol – KSWO 7News

    Comanche Nation Entertainment Closes Casino Near Devol in Surprising Move

  • General
  • Health
  • News

    Cracking the Code: Why China’s Economic Challenges Aren’t Shaking Markets, Unlike America’s” – Bloomberg

    Trump’s Narrow Window to Spread the Truth About Harris

    Trump’s Narrow Window to Spread the Truth About Harris

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    Israel-Gaza war live updates: Hamas leader Ismail Haniyeh assassinated in Iran, group says

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    PAP Boss to Niger Delta Youths, Stay Away from the Protest

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Court Restricts Protests In Lagos To Freedom, Peace Park

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Fans React to Jazz Jennings’ Inspiring Weight Loss Journey

    Trending Tags

    • Trump Inauguration
    • United Stated
    • White House
    • Market Stories
    • Election Results
  • Science
  • Sports
  • Technology
    Gene Associated With Deadly Heart Disease in Golden Retrievers Identified – Technology Networks

    Breakthrough Discovery Uncovers Gene Behind Deadly Heart Disease in Golden Retrievers

    Monkey Island LNG Picks ConocoPhillips’ Liquefaction Technology – Hart Energy

    Monkey Island LNG Selects ConocoPhillips’ Advanced Liquefaction Technology for Next-Gen Energy Solutions

    Credo Technology Group Holding Ltd. (CRDO) Surpasses Q1 Earnings and Revenue Estimates – Yahoo Finance

    Credo Technology Group Surpasses Q1 Earnings and Revenue Expectations

    The Economist is hiring a science and technology correspondent – The Economist

    Exciting Opportunity: Become Our Next Science and Technology Correspondent!

    Blockchain lender Figure Technology seeks to raise up to $526M in IPO (FIGR:Pending) – Seeking Alpha

    Blockchain Lender Figure Technology Sets Sights on $526M in Thrilling IPO Launch

    New Technology from Ramsey Theory Group Brings Diagnostic Testing and Telehealth Directly into Patients’ Homes – Yahoo Finance

    Revolutionary Ramsey Theory Technology Delivers Diagnostic Testing and Telehealth Right to Your Doorstep

    Trending Tags

    • Nintendo Switch
    • CES 2017
    • Playstation 4 Pro
    • Mark Zuckerberg
No Result
View All Result
Earth-News
No Result
View All Result
Home Business

: Amgen to continue to seek full approval of Lumakras cancer drug after FDA panel votes against it

October 6, 2023
in Business
: Amgen to continue to seek full approval of Lumakras cancer drug after FDA panel votes against it
Share on FacebookShare on Twitter

Amgen Inc. said it would continue to work closely with the Food and Drug Administration to seek full approval for its Lumakras cancer drug as a treatment for a form of lung cancer, after an advisory panel found fault with a late-stage trial on Thursday.

The drug was granted approval in 2021 under an accelerated program that was conditional on further confirmatory trials. The panel gathered Thursday to review data from a Phase 3 trial dubbed CodeBreak 200 that evaluated Lumakras as a treatment for patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC).

The panel was asked to vote on whether the primary endpoint, progression-free survival (PFS) per blinded independent central review (BICR), could be reliably interpreted and voted 10 to 2 that it could not.

The FDA is not obliged to follow the panel’s recommendations but it often does.

“We will continue to progress our comprehensive global KRASG12C inhibitor development program exploring multiple LUMAKRAS combination regimens, including in colorectal cancer,” Amgen said in a statement. “We will continue to work closely with the FDA on the full approval pathway for this important medicine.”

The panel’s vote was based on its determination that the trial had “multiple sources of systemic bias,” according to documents that were published earlier this week.

Experts found that the trial allowed too many patients to switch between the control and treatment arms and that too many withdrew consent for the data to be relied on.

“The trial results are confounded by multiple sources of systemic bias, raising concerns about whether CodeBreaK 200 can be considered an adequate and well controlled trial,” said the documents. “Furthermore, the primary endpoint of PFS by BICR may not be reliable, given its magnitude relative to the imaging interval (5 weeks vs 6 weeks).”

Mizuho analysts said the fact that the purpose of the meeting was not to remove Kumakras from the market was a positive for future oncology trials.

“We see the potential for increased scrutiny of trials when the effect size is determined to be low, as seemed to be indicated by the FDA’s review,” wrote analyst Mara Goldstein in a note to clients.

“Over the past two years the FDA has increased the demand for confirmatory trials –in the context of Accelerated Approval — and it does not appear that this will lessen in the near term, but we see oncology valuations already reflecting that.”

Amgen said that to date, over 15,000 patients worldwide have received Lumakras.

The stock was flat premarket and has gained 0.3% in the year to date, while the SPDR S&P Biotech ETF
XBI
has fallen 13% S&P 500
SPX
has gained 11%.

>>> Read full article>>>
Copyright for syndicated content belongs to the linked Source : MarketWatch – http://www.marketwatch.com/news/story.asp?guid=%7B20C06575-04D4-B545-7277-CD9FE4CF2E51%7D&siteid=rss&rss=1

Tags: AmgenApprovalbusiness
Previous Post

Help Me Retire: I’m 67 and retired with $2 million after investing in McDonald’s and Facebook — but now I think I should ‘park my money.’ What should I do? 

Next Post

Financial Literacy Is a Serious Concern. GravyStack Is Addressing It In an Unexpected Way– Through Play

News – Ancient DNA Pinpoints Culprit Responsible for World’s First Pandemic – Archaeology Magazine

Ancient DNA Reveals the True Cause of the World’s First Pandemic

September 5, 2025
Fears of US recession as economy adds just 22,000 jobs – The Times

Fears of US recession as economy adds just 22,000 jobs – The Times

September 5, 2025
Musiq Soulchild Surprises Fan’s Bride With “Dontchange” Wedding Serenade – yahoo.com

Musiq Soulchild Captivates Wedding Guests with Heartfelt Serenade of “Don’tchange

September 5, 2025
States fight feds over future of school mental health services – Courthouse News Service

States Clash with Federal Government Over the Future of School Mental Health Services

September 5, 2025
The Florida GOP ending vaccine mandates is playing with fire – CNN

Florida GOP’s Move to End Vaccine Mandates Could Spark Serious Consequences

September 5, 2025
George M. Sutton Urban Wilderness in Norman to Undergo Ecological Restoration Project in September – Hoodline

Transforming George M. Sutton Urban Wilderness: Exciting Ecological Restoration Kicks Off This September

September 5, 2025
White House cuts to science funding threaten AI weather forecasting institute – NBC News

White House Funding Cuts Jeopardize Future of AI-Powered Weather Forecasting Institute

September 5, 2025
The Mediterranean diet has benefits backed by science – ECB Publishing, Inc.

Unlock the Powerful Health Benefits of the Mediterranean Diet Backed by Science

September 5, 2025
Retire in This Asian Country for a Warm Culture and Relaxed Lifestyle – Kiplinger

Retire in This Asian Country for a Warm Culture and Relaxed Lifestyle – Kiplinger

September 5, 2025
Gene Associated With Deadly Heart Disease in Golden Retrievers Identified – Technology Networks

Breakthrough Discovery Uncovers Gene Behind Deadly Heart Disease in Golden Retrievers

September 5, 2025

Categories

Archives

September 2025
MTWTFSS
1234567
891011121314
15161718192021
22232425262728
2930 
« Aug    
Earth-News.info

The Earth News is an independent English-language daily published Website from all around the World News

Browse by Category

  • Business (20,132)
  • Ecology (808)
  • Economy (827)
  • Entertainment (21,704)
  • General (16,874)
  • Health (9,868)
  • Lifestyle (840)
  • News (22,149)
  • People (828)
  • Politics (834)
  • Science (16,037)
  • Sports (21,325)
  • Technology (15,807)
  • World (808)

Recent News

News – Ancient DNA Pinpoints Culprit Responsible for World’s First Pandemic – Archaeology Magazine

Ancient DNA Reveals the True Cause of the World’s First Pandemic

September 5, 2025
Fears of US recession as economy adds just 22,000 jobs – The Times

Fears of US recession as economy adds just 22,000 jobs – The Times

September 5, 2025
  • About
  • Advertise
  • Privacy & Policy
  • Contact

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

No Result
View All Result

© 2023 earth-news.info

Go to mobile version