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Do you have life threatening disease lung cancer? New blockbuster cancer drug coming your way from big pharma
- Thread starter ginfreely
- Start date
You have CB cancer.
This Is Why Amgen's New Cancer Drug Could Be Huge
CONTRIBUTORCory Renauer The Motley Fool
PUBLISHED
JUN 2, 2021 6:13AM EDT
Biotechnology stocks are famous for dramatic price movements but smart investors have been eager to scoop up shares of Amgen (NASDAQ: AMGN) for a different reason. Despite a development pipeline that few analysts would describe as prolific, investors who have held the stock over the past decade have gained more than 400% once you factor in dividends.
Despite its size, Amgen can move quickly where it matters most. On May 28, 2021, the FDA granted a highly accelerated approval to a new lung cancer therapy in record time. This is why Lumakras could allow this biotech stock to deliver oversized gains for at least another decade.
A long time coming?
Scientists have known that mutant KRAS proteins were responsible for aggressive tumor growth for decades, but they aren't easy to manipulate. Once Amgen realized Lumakras could tackle aggressive cancer cases the company turbocharged its development.Amgen announced the first human proof-of-concept data for Lumakras in 2019 when it was still known as AMG 510. Amgen used the FDA's new Orbis pathway to expand and adapt that first trial in a way that satisfied all the necessary criteria for accelerated approval.
Lumakras is the first KRAS inhibitor to earn approval but it isn't the only one in development at the moment. Adagrasib from Mirati Therapeutics(NASDAQ: MRTX) aims for KRAS proteins with the same G12C mutation. Mirati expects to submit an application for accelerated approval before the end of 2021, but the timeline's still a little fuzzy.
Blockbuster potential
With a head start on the competition, Lumakras seems likely to reach a large share of the available pool of KRAS-positive patients before Mirati Therapeutics has a chance to launch a competing drug. Oncologists have noticed KRAS G12C activity in around 14% of all cases of non-small-cell lung cancer (NSCLC) and 3% to 4% of colon cancer cases.
Less cigarette smoking and more early screening have lowered the risk of death from lung cancer a great deal, but roughly 6% of Americans will be diagnosed with lung cancer at some point in their lives. Since most cases aren't discovered until advanced stages, only around one in five patients survive more than five years after receiving their first lung cancer diagnosis.
In the study supporting its accelerated approval, Lumakras shrank tumors for 36% of KRAS-G12C positive NSCLC patients. These were patients with tumors that continued growing despite treatment with standard care, so eliciting responses from more than a third is impressive.
In the study supporting its accelerated approval, Lumakras shrank tumors for 36% of KRAS-G12C positive NSCLC patients. These were patients with tumors that continued growing despite treatment with standard care, so eliciting responses from more than a third is impressive.
To help oncologists discern which patients might benefit from Lumakras, the FDA also approved a blood-based diagnostic from Guardant Health(NASDAQ: GH). This means new patients won't necessarily need a biopsy to begin treatment with Lumakras.
To see what could be in store for Lumakras, we can look at AstraZeneca's (NASDAQ: AZN)experience with Tagrisso a targeted treatment for NSCLC patients with EGFR mutations. Although first approved for a second-line setting about six years ago, a subsequent approval to treat first-line patients in 2019 pushed Tagrisso sales up to $4.3 billion last year.
We'll know more about Lumakras' future before too long. Amgen has already completed enrollment into a phase 3 study that compares Lumakras to standard chemotherapy.
What's next
At the moment, Lumakras is approved to treat NSCLC patients who have already relapsed or failed to respond to their first course of treatment. This is an important population but it isn't nearly as large as the pool of newly diagnosed patients who tend to remain on treatment much longer. With a list price of around $18,000 per month, an expansion to the first-line setting could lead to a revenue explosion for Amgen.To see what could be in store for Lumakras, we can look at AstraZeneca's (NASDAQ: AZN)experience with Tagrisso a targeted treatment for NSCLC patients with EGFR mutations. Although first approved for a second-line setting about six years ago, a subsequent approval to treat first-line patients in 2019 pushed Tagrisso sales up to $4.3 billion last year.
We'll know more about Lumakras' future before too long. Amgen has already completed enrollment into a phase 3 study that compares Lumakras to standard chemotherapy.
Of course provided you have USD18,000 per month to pay for it.
Oh so test on 124 patients already can get accelerated approval from FDA.
https://medcitynews.com/2021/05/amg...ug-targeting-elusive-mutation-in-lung-cancer/
Accelerated approval of Lumakras was based on the results of a Phase 2 study that tested the therapy in 124 patients whose KRAS G12C-driven NSCLC had progressed after receiving treatment with an immunotherapy called a checkpoint inhibitor, and/or chemotherapy.
The main goal of the open-label study was to measure the objective response rate, which is the proportion of patients whose tumors were destroyed or reduced in size, as well as the duration of the response. The FDA said that the objective response rate was 36%. Of those who responded to treatment, 58% had a response that lasted six months or longer. Overall survival data, the length of time patients are still alive after the start of treatment, are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology next month.
The most common side effects reported in the clinical trial included diarrhea, muscle pain, nausea, fatigue, liver damage, and cough. The FDA said that treatment with Lumakras should be withheld if patients develop symptoms of interstitial lung disease, a condition that causes scarring of the organ. If the disease is confirmed, the use of the drug should stop. If liver damage develops, the FDA said that the drug should be withheld, the dose reduced, or its use can be discontinued permanently.
https://medcitynews.com/2021/05/amg...ug-targeting-elusive-mutation-in-lung-cancer/
Accelerated approval of Lumakras was based on the results of a Phase 2 study that tested the therapy in 124 patients whose KRAS G12C-driven NSCLC had progressed after receiving treatment with an immunotherapy called a checkpoint inhibitor, and/or chemotherapy.
The main goal of the open-label study was to measure the objective response rate, which is the proportion of patients whose tumors were destroyed or reduced in size, as well as the duration of the response. The FDA said that the objective response rate was 36%. Of those who responded to treatment, 58% had a response that lasted six months or longer. Overall survival data, the length of time patients are still alive after the start of treatment, are scheduled to be presented at the annual meeting of the American Society of Clinical Oncology next month.
The most common side effects reported in the clinical trial included diarrhea, muscle pain, nausea, fatigue, liver damage, and cough. The FDA said that treatment with Lumakras should be withheld if patients develop symptoms of interstitial lung disease, a condition that causes scarring of the organ. If the disease is confirmed, the use of the drug should stop. If liver damage develops, the FDA said that the drug should be withheld, the dose reduced, or its use can be discontinued permanently.
Wow not bad expected to use for other cancers too.
https://medcitynews.com/2021/05/amg...ug-targeting-elusive-mutation-in-lung-cancer/
Amgen aims to broaden use of Lumakras to other cancers. The company is also conducting a Phase 2 test of its drug in colorectal cancer. The company said that clinical trial is fully enrolled and preliminary results are expected later this year. A global Phase 3 study is underway comparing the drug to the chemotherapy docetaxel in NSCLC patients with the KRAS G12C mutation.
Approval of Lumakras, which will be given as a 960 mg dose (eight 120 mg tablets taken once daily), came more than two months early. The target date for a decision was August 16. The accelerated approval, based on a thinner body of evidence than is typically evaluated in a standard drug review, requires Amgen to conduct additional clinical research to test whether a lower dose will have a similar effect.
https://medcitynews.com/2021/05/amg...ug-targeting-elusive-mutation-in-lung-cancer/
Amgen aims to broaden use of Lumakras to other cancers. The company is also conducting a Phase 2 test of its drug in colorectal cancer. The company said that clinical trial is fully enrolled and preliminary results are expected later this year. A global Phase 3 study is underway comparing the drug to the chemotherapy docetaxel in NSCLC patients with the KRAS G12C mutation.
Approval of Lumakras, which will be given as a 960 mg dose (eight 120 mg tablets taken once daily), came more than two months early. The target date for a decision was August 16. The accelerated approval, based on a thinner body of evidence than is typically evaluated in a standard drug review, requires Amgen to conduct additional clinical research to test whether a lower dose will have a similar effect.
How about your brain cancer? No cure?
Only you malaysian IndianS psychopathS persecuting me for years got brain cancer
I prefer to use dog anti parasitic pills. Cheaper
Interaction of tumor suppressor protein p53 and DNA.
Could a drug used to treat tapeworms be effective at treating a type of cancer? Researchers in Singapore think they are on the right track in demonstrating just that.
Scientists from A*STAR’s Institute of Molecular and Cell Biology (IMCB) recently discovered that the use of niclosamide, which is on the World Health Organization’s list of essential medicines, can effectively kill p53-defective cancer cells. This discovery means that the anti-parasitic medicine has the potential to increase the specificity for cancer targeting and sparing normal cells that carry wildtype p53, either the natural of non-mutated form, Singapore’s Agency for Science, Technology and Research reported on Friday. These findings were published in leading scientific journal Nature Communications, the government agency said.
The drug, which was first discovered in the 1950s, has been of interest to researchers across the globe for some time due to its potential as a cancer-fighting medication. Over the past five or so years, there have been a number of articles published about the medicine’s potential as an inhibitor of various cancer pathways. In 2015, the medication showed potential in treating methicillin-resistant Staphylococcus aureus (MRSA) cultures in a laboratory setting. Regarding the most recent work in Singapore, mutations of the p53 gene in the human body is one of the most common occurrences found in cancer cells and is present in over 50 percent of cancers. The p53 gene is a tumor suppressor gene that inhibits the growth of tumors, and if this gene is mutated, cancer cells are able to thrive, the government agency said.
Tapeworm Drug Could Be an Effective Treatment for Certain Cancers
Published: Feb 19, 2019 By Alex KeownInteraction of tumor suppressor protein p53 and DNA.
Could a drug used to treat tapeworms be effective at treating a type of cancer? Researchers in Singapore think they are on the right track in demonstrating just that.
Scientists from A*STAR’s Institute of Molecular and Cell Biology (IMCB) recently discovered that the use of niclosamide, which is on the World Health Organization’s list of essential medicines, can effectively kill p53-defective cancer cells. This discovery means that the anti-parasitic medicine has the potential to increase the specificity for cancer targeting and sparing normal cells that carry wildtype p53, either the natural of non-mutated form, Singapore’s Agency for Science, Technology and Research reported on Friday. These findings were published in leading scientific journal Nature Communications, the government agency said.
The drug, which was first discovered in the 1950s, has been of interest to researchers across the globe for some time due to its potential as a cancer-fighting medication. Over the past five or so years, there have been a number of articles published about the medicine’s potential as an inhibitor of various cancer pathways. In 2015, the medication showed potential in treating methicillin-resistant Staphylococcus aureus (MRSA) cultures in a laboratory setting. Regarding the most recent work in Singapore, mutations of the p53 gene in the human body is one of the most common occurrences found in cancer cells and is present in over 50 percent of cancers. The p53 gene is a tumor suppressor gene that inhibits the growth of tumors, and if this gene is mutated, cancer cells are able to thrive, the government agency said.
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