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FDA Gives Nod to “Miracle” Breast Cancer Drug Reducing Disease Progression and Death by 72%

AMAC Exclusive – By Andrew Abbott


While COVID-19 and developments surrounding therapeutics and vaccines dominated coverage of the medical world throughout 2021, the United States also saw a slew of new medical innovations and therapies for other ailments. Although the broad media landscape took shockingly little note of them, these innovations and life-saving interventions could help millions of suffering patients see substantive improvement in their lives.

Among the most notable breakthroughs was the announcement that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to a new drug, Enhertu (trastuzumab deruxtecan), which can reportedly “reduce the risk of disease progression or death by 72%” in patients with HER2-positive breast cancer, one of the most aggressive forms of breast cancer.

Despite billions of dollars spent on awareness, early detection efforts, and novel therapies, breast cancer is still the most common cancer worldwide. In 2020 alone, there were more than two million diagnosed cases, with considerably more likely going undetected. The disease also accounted for almost 685,000 global deaths that year.

On average, one in five of those two million cases were “HER2 positive.” Human Epidermal Growth Factor Receptor 2, also known as HER2, is a protein that promotes the growth of cancer cells. In HER2-positive breast cancer cases, the patient has extra copies of the gene. This means that the cancer is significantly more aggressive than in other cases. Being HER2-positive can dramatically affect a patient’s prognosis, treatment, and even survival rate. For this reason, HER2 is tested for very early and often in patients with breast cancer.

The new drug, Enhertu, developed by pharmaceutical corporation AstraZeneca, is for HER2-positive breast cancer patients who cannot have the cancer surgically removed, or have a metastatic cancer case where the cancer is spreading throughout the body. According to findings in clinical trials, Enhertu is 72% more effective at reducing the risk of “disease progression or death” than the current drugs used to treat HER2-positive patients.

Based on these promising results, the FDA in October granted Enhertu Breakthrough Therapy Designation (BTD). First approved for use in 2012, BTD allows the FDA to grant priority review to therapies that demonstrate “the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.” It is one of several tools the FDA has to essentially “fast track” drugs whose early clinical trials suggest an immediate and significant effect on the treatment of life-threatening conditions.

AstraZeneca Oncology R&D Executive Vice President Susan Galbraith hailed the approval, stating, “This is an important step in bringing Enhertu as a potential new option in earlier lines of treatment for HER2-positive metastatic breast cancer, given the urgent need to improve outcomes. This recognition by the FDA underscores the transformative possibility of Enhertu.”

Although there is no specific timeline for when the drug may become available to all HER2-positive breast cancer patients, data suggests that drugs granted BTD spend two to three years less time in pre-market development and have shortened review periods as well. Enhertu is already available for breast cancer patients with more advanced HER2-positive cases, and BTD designation means it may soon be approved for more mild cases in the coming months.

Without these fast-track programs, drugs with incredible life-saving potential would otherwise get lost in mounds of bureaucratic red tape and might not get approved for years. As of August 2020, 298 drugs have been brought to market under BTD. As a recent example of what can happen without some measures to prioritize promising drugs, the failures of the FDA to quickly approve an effective rapid test for COVID-19 were primarily blamed on onerous red tape and other bureaucratic hurdles. Critics claim that were it not for these delays, the proliferation of the disease across America could have been significantly reduced.

President Donald Trump’s Operation Warp Speed was another example of how expediting approvals by removing unnecessary bureaucratic red tape can help save lives. Many legislators and doctors are hopeful that programs like Operation Warp Speed and breakthrough therapy designation will be adopted across the FDA with the hope of accelerating approval for other life-saving medical innovations like Enhertu in the future.

Andrew Abbott is the pen name of a writer and public affairs consultant with over a decade of experience in DC at the intersection of politics and culture.

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Delia Rose
1 year ago

Making drugs available without the normal process has caused many to suffer and die. We are never told the truth. If Gates and Fauci are involved, there should be warnings!!!

anna hubert
1 year ago

there goes that word again “it may” how many times over decades and billion dollars spent on research have we heard that?

1 year ago

Funny thing………they discovered a cure for cancer in the late 1700s. You would not be told of this because the pharmaceutical companies would go out of business. Oh well……..

1 year ago

They make too much money on cancers: doctors, hospitals, equipment, BIG pharma, AMA, FDA, politicians, and the lists goes on and on………………………….! The billions of $$$$$$$$$$$ bought a lot of 2nd homes and luxury new cars!!!!! Will they find a cure?

1 year ago

I love seeing all the different “DRUG” commercials on the different sites with a magical pill that will cure all with one million side effects so check with your doctor — I don’t trust the Food and Drug Administration as well as the FDC for the false information they are putting out to the public.

1 year ago

The medical community which is largely controlled by pharmaceutical companies the fda and the ama, mostly laughs off holistic medicine. The md’s who use it get better results. David brownstein, in his book, iodine and why you need it, tells of it’s use in breast tissue. We’re told mcg’s are necessary, but mg’s are what are consumed in countries where breast ca is lowest. I currently take one hundred mg’s per week for another issue and have taken that much and more for several years. I’m still alive.

Elena Tellez
1 year ago

This ‘experimental’ drug should be available NOW… to people who would otherwise die of (specific types of) breast and metastatic breast cancers. After 30+ years in Big Pharma, any delay they can foment means more money for them, plus (many, but not all) doctors and hospitals, who are all about profit… money, money, money… and human life be damned. Let’s petition our representatives and Senators to push this through. WHY is it always about the MONEY, folks… does no one have compassion for human pain and suffering???

1 year ago

Trillions of dollars have been donated for breast cancer research & development & no cure yet…. where did that money go? same with other cancers…. is the current horrific treatment so profitable that the research & development money is shifted to non-promising research? essentially wasted?

anna hubert
1 year ago
Reply to  Momcat

Exactly it is a huge business that would collapse if the disease disapeared

1 year ago

I have always felt, and seen often, that as soon as the federal finger is in the pie everything gets screwed up, almost instantly. Only rarely have the effects of the federal government been quick applicable and fitting to the need or event. Even a weather disaster falls to their muddling. Drugs and treatments have long been dragged through the burecratic red tape, leaving lives lost and damaged in the wake of approvals, which, in other parts of the world have gained lives and reduced suffering, simply because the government agencies are not standing in the way. Only in America do we have this over-arching fear of error or mistakes….mostly fueled by corporations who are trying to avoid law suits and prime their profit pumps. Graft, under the table deals and the like are the rule of order for the FDA, not the betterment of the people…..note the last paragraph in this article… pressure works to force the government to do its job in a direct and timely manner…..for the good…..and that’s how it should be all along the way. Who knows how many lives have been lost or ruined because the FDA and other agencies fill the path to success with hoops, chutes and ladders only their buddies and financial supporters can navigate. Trump managed to streamline and activate the process, but he had to do it by force, and made some enemies along the way….some of whom are now and have been on the attack because he offered to do what was best and right for the people in need.

1 year ago

Cruciferous vegetable,iodine and vit.D is a good place to start.

1 year ago
Reply to  Tom

I agree with you about cruciferous vegetables. There isn’t a day that goes by when I haven’t eaten at least one of them.

One thing our doctors don’t tell us, and often are themselves unaware, is that chopping fresh broccoli, cabbage, kale, pac choi, Brussels sprouts, and others 30-40 minutes before cooking releases beneficial compounds. Bruising the plant’s cells activates a plant enzyme, called myrosinase, which transforms some of the antioxidants into the sulforaphanes. Myrosinase is inactivated by heat, so cooking kills many of the beneficial antioxidants. These substances aren’t present in other edible crops and have been linked with lower rates of cancer and positive results using brassicas for treating cancer. (Never overcook the brassicas and steam or stir fry at low-medium heat.)

There are several other illnesses and inflammatory diseases that can be helped by eating more brassicas. Not a miracle cure…consult your doctor or one who’s better informed. Nutrition facts dot org has many videos citing credible research throughout the world.

Easy to grow from seed…highly recommended by at least 2 of us. Yes, also D3 and a few others every day. Merry Christmas, and a healthy one with a big helping of broccoli.

1 year ago
Reply to  Kim

Had some last night.

1 year ago
Reply to  Wanda

Great!…and tonight?

1 year ago

Useless in the end. When these “life saving” medicines come out, they have price tags of thousands of dollars per month on them.
So the wealthy get treatment. The rest of America dies.
Big F’ing deal.

anna hubert
1 year ago
Reply to  Becky

Often life saving really means prolonging the inevitable

1 year ago
Reply to  Becky

My doctor prescribed Ozempic to lower my glucose …. I am blessed that I have insurance that pays most of it….it costs me $60 a month…but before my insurance approved it I tried to use the little plastic card that reduces your prescription cost and my cost would have been over $800….I got a renewal yesterday and noticed that my insurance had saved me $916 which would make it $976 a month. You are correct….the poor and people without prescription medicine insurance just have to do without. If it were not for my insurance, I surely would. Sad …. very sad.

Stephen Russell
1 year ago

Side note: US Army develop Univaccine RX to counter all virus plagues for future

1 year ago

I, for one, don’t care one hoot for any of these “wonderful” new drug cures. At 74, I still work 8-10 hours a day, 7 days a week and can do so because I believe and practice Natural Alternative Prevention!
Because I have a pemf medical device from Germany, I have NO clogged arteries, NO high cholesterol, NO high blood pressure and NO high blood sugar! I feel and look many year’s younger than people who are actually many, many years younger! I don’t trust doctors who are quick with the prescription pad!

Sharon Ormsby
1 year ago

This doesn’t help my friend Jan, who died of this disease. No parent who exhibited the disease beforehand. No sister sibling to suggest she would have this type of breast cancer. She fought valiantly, but succumbed in the end. It might help her daughter now, the despicable one, who never came to see her, however.

1 year ago
Reply to  Sharon Ormsby

I, too, have lost friends and relatives to breast cancer. One, a close friend (divorced, no children) from our middle school years, took part in research studies, which provided valuable information to further medical knowledge. She died, but she willingly participated in the process. That was a contribution she was able to make. We will get there, and the meds will become available, even though it might not be a direct route.

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