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Sandeep Singh Dhillon
Blood-Based Breast Cancer Detection Test May Help Avoid Biopsy – Forbes
Analytical Discussion, Pharma News, Pharmaceutical & Drug Delivery Journals

By John Nosta

Early detection of cancer is one of the most powerful tools in the management of this disease. And while imaging modalities have advanced the ability to detect early disease, challenges still exist for both clinician and patient. Yet one point remains clear and is a driving principle—early detection saves lives. And the earlier, the better.

A study published in Clinical Breast Cancer examined the utility of blood markers to detect breast cancer. The test that was evaluated is called Videssa Breast and evaluates 11 serum protein biomarkers and 33 tumor-associated autoantibodies. It was studied in women under 50 who had abnormal or difficult-to-interpret imaging (BI-RADS 3 and 4).

Here’s the overall takeaway: The negative predictive value—the likelihood of a patient having no cancer—was 99%. In other words, clinicians may have a powerful tool to identify patients who are highly unlikely to have breast cancer, in instances where the mammogram is abnormal. Overall, imaging resulted in 341 participants receiving follow-up procedures to detect 30 cancers (90.6% FP rate). Videssa Breast would have recommended 111 participants for follow-up, a 67% reduction in false positives. The authors conclude:

Videssa Breast can effectively detect breast cancer when used in conjunction with imaging and can substantially reduce unnecessary medical procedures, as well as provide assurance to women that they likely do not have breast cancer.

While the results are impressive, the clinical path itself can be difficult. Primary care physicians, radiologists and surgeons all play a role in patient management. And the decision for invasive procedures such as a biopsy involves these stakeholders—and the patient. I presented the study to three of these decision-makers for their perspective on a blood-based test used in association with mammography.

The primary care physician:

I see these diagnostic uncertainties after breast cancer screening almost daily. When a mammogram comes back abnormal, I can tell my patient that it appears benign. But with Videssa Breast, I can give her much more powerful reassurance that it is not cancer. Having used the test for some time, my goal is to educate other providers about it, because I’ve seen it serve as a valuable decision-making tool that helps spare women potentially unnecessary biopsy. Most women who get that abnormal imaging result do not have cancer. With the simplicity of a blood test, I can send more of them home with peace of mind.

—Wendell Phillips, D.O., primary care physician with HonorHealth Medical Group in Phoenix, Ariz.

The radiologist:

As a radiologist, images don’t always give us a clear view of a patient’s cancer status. A blood test that offers clinicians the confidence to rule out cancer can help us better select the patients who truly need closer monitoring or that next intervention. In the case of breast biopsy, the test is a powerful avenue for reducing the use of an invasive procedure and still get to best outcomes for women.

—Josie R. Alpers MD, radiologist and study co-author

The surgeon:

Clearly this type of liquid biopsy test is the direction we are going with many cancers. As mammography technology has improved, we are finding many things that we have to act on, but may be clinically insignificant. I can see that increasing with the adoption of this technology—at least until we have gotten over our learning curve. However, there is no question that patients who have a BIRADS 3 mammogram and high anxiety about six-month follow up may be relieved by a negative Videssa test.

—Deanna Attai, M.D., past president, the American Society of Breast Surgeons

For solid tumors, the combination of an anatomic view and biological view may hold the promise to more sophisticated detection and management. Further, we may also gain new insights into other pathology such as atypical hyperplasia and how to best manage these conditions. But beyond the deeply scientific aspect of cancer detection lie deep personal and emotional aspects of this disease. The burden is tremendous and the ambiguities of diagnosis can add to the difficulties. A new test, particularly one with a high negative predictive value, can be a potent source of comfort that offers, in and of itself, a level of therapeutic value. And as more data become available, the potential for expanded use of Videssa Breast as a screening tool could be a game-changer in the diagnosis and management of breast cancer.

Sandeep Singh Dhillon
The world’s largest drugmaker thinks it has 11 billion-dollar drugs in the pipeline : here’s what they treat – Business Insider
Drug Discovery, Pharma News, Pharmaceutical & Drug Delivery Journals

Johnson & Johnson just listed out the drugs it plans to file for approval over the next few years that could be “blockbusters.”

These are drugs that haven’t been approved yet, but by 2021, they could be making more than $1 billion in annual sales each.

Right now, the world’s largest drugmaker is known for its immunology drugs like Remicade, which made $4.8 billion in sales in 2016 and Stelara, as well as the bloodthinner Xarelto, which made $2.2 billion in sales in 2016.

Here’s the list of drugs J&J plans to file for approval over the next four years that could hit that blockbuster threshold, including cancer and depression treatments:

guselkumab – psoriasis (Filed for approval in 2016)
sirukumab – rheumatoid arthritis (Filed for approval in 2016)
apalutamide – pre-metastatic prostate cancer
esketamine – treatment-resistant depression
talacotuzumab – acute myeloid leukemia, a type of blood cancer
erdafitinib – solid tumors
niraparib – prostate cancer
imetelstat – myelofibrosis, a bone marrow disorder
pimodivir – influenza A
lumicitabine – respiratory syncytial virus (RSV) infection
JNJ-7922 – adjunctive treatment for major depressive disorder

US FDA grants Kitova a waiver for new drug application filing fee
Drug Discovery, Pharma News, Pharmaceutical & Drug Delivery Journals

Sandeep Singh Dhillon
This new medication can cure moderate to severe psoriasis – MIMS Malaysia
Drug Discovery, Pharma News, Pharma Notables, Pharmaceutical & Drug Delivery Journals

A new drug called ixekizumab succeeded in clearing psoriasis in about 80 percent of patients in three large, long-term clinical trials.

Shortly after the trials were completed, the Food and Drug Administration gave its approval for drug distribution, Science Daily reported.

Dr Kenneth Gordon, the paper’s first author and a professor of dermatology at Northwestern University Feinberg School of Medicine, said the group of studies indicated very high and consistent levels of safety and efficacy. It also had a great majority of responses which persisted for at least 60 weeks, which was noteworthy.

Psoriasis is an immune-mediated inflammatory disease that causes red, dry and itchy skin. It affects about 3 percent of the world’s population and is linked to an increased risk of diabetes, depression and heart disease.

Ixekizumab clears psoriasis by neutralising a pathway in the immune system known to promote the disease.

To test the drug’s efficacy over time and to determine whether its benefits outweigh the risks, three clinical trials enrolled 3,736 adult patients at more than 100 study sites in 21 countries. Researchers randomised patients to receive either injections of ixekizumab at various doses or a placebo over a period of more than a year.

All participants suffered from moderate to severe psoriasis, which is defined as covering 10 percent or more of the body, the report said.

The investigators found after 12 weeks that 76.4 to 81.8 percent of patients had their psoriasis classified as “clear” or “minimal” capered to just 3.2 percent of patients on the placebo group. By week 60, 68.7 to 78.3 percent of patients had maintained their improvement.

The new drug is associated with such adverse effects as slightly higher rates of neutropenia (low white blood cell count), yeast infection and inflammatory bowel disease.

“As with any treatment, the benefits need to be weighed against the risks of adverse events,” researchers noted, adding that the efficacy and safety of ixekizumab beyond 60 weeks of treatment are not yet known.

The findings were compiled in a paper published in the New England Journal of Medicine. MIMS

Antihistamines: What they didn’t teach us in school – MIMS Malaysia
Pharma Notables, Pharmaceutical & Drug Delivery Journals

Antihistamines are ‘good old drugs’ that have a long history of use. H1 antihistamines work on the histamine-1 receptors as inverse agonists or antagonists to provide relief for conditions such as allergic rhinitis, urticaria and motion sickness. H2 antihistamines target receptors primarily in the upper gastrointestinal tract and stomach, providing relief for gastric conditions such as peptic ulcer and acid reflux. Since its discovery in the last century, H1-antihistamines have been topping medication sales billboards, proving to be a safe and effective symptomatic remedy for common ailments. Are antihistamines really a true saviour, or a wolf in sheep’s disguise?

The first antihistamine in history

The first antihistamine was discovered as a voyage experiment to search for a substance that can antagonise histamines. In 1937, scientist Daniel Bovet wrote about the presence of three naturally occurring amines – acetylcholine, epinephrine and histamines, which all have a similar chemical structure. He observed that these chemicals were naturally present in-vivo, and they interfere with the effects of acetylcholine. Bovet’s work led to the discovery of the first H1-antihistamine (i.e. antergen) in 1942, followed by diphenhydramine in 1945.

H1 antihistamines in the 21st century

Today, extensive research on H1 antihistamines is conducted, resulting in the development of innumerable chemical structures bearing anti-histaminergic effects in the market. These agents are made into various dosage forms including oral syrup, oral tablet, topical creams and gels as well as nasal sprays. Different chemical compounds have slightly different mechanisms of action, bind to receptors with different affinity, have different absorption and metabolism pharmacokinetics and different side effect profiles. Drug companies tap on these differences as marketable unique selling points to target different audiences.

Antihistamines now – Things to note

1. Easy access, highly affordable and relatively safe

There are few antihistamines that remain as a prescription only medication (POM) in the market. Most are readily available as pharmacy-only (P-only) item or over-the-counter (OTC) item. This ease of purchase has led to a widespread use of antihistamines. Owning to its relatively safe profile, we have seen more antihistamines, especially the non-sedating second generation antihistamines getting delisted from P-only item to OTC status, making it even more accessible to the public. Prices for antihistamines have also skydived from being exclusive to cheap over the past decade due to generics.

2. The “family antihistamine” phenomenon

Allergies have a genetic component. Patients with a history of allergies sometimes come to the pharmacy to ask for an antihistamine not for themselves, but for the family. They reside in the same environment, eat similar food, face the same allergens and sometimes have the same type of allergic reactions. The lack of surveillance of sale of antihistamines, unlike potentially abusive medications, also allows patients to get stock for more than oneself at any one time. Dinnertime conversation exaggerates this phenomenon as family members discuss this miracle medication, which is cheap, good, effective and safe.

3. Creative names for impact

Brand names of medications are created to deliver impact and attract customers. Drug names peppered with tricatives such as X and Z are fast sounding words, implying that these medications work faster. It is no wonder that sometimes patients are more inclined to purchase antihistamines with brand names with such fast sounding tricatives due to the idea of immediate symptomatic relief.

Realise that it is not a one size fit all

Many pharmacists today will applaud the act of delisting antihistamines from P-only to OTC items, as we deemed antihistamines to be relatively safe medications. Second generation antihistamines are especially popular due to the non-sedating side effect profile and long duration of action. However, missing out on the following caveats may endanger a patient.

1. Elderly and antihistamines use

1st generation antihistamines crosses the blood brain barrier and are therefore sedating. We know that they can cause drowsiness and this effect is especially prominent in the elderly. What one often fails to realise is the consequences of the excessive somnolence, leading to avoidable falls and accidents. Antihistamines with anticholinergicity can also worsen glaucoma, constipation, acute urinary retention, all of which are medical conditions commonly present in the geriatric population. They are also more likely to be on medications that can have potential drug interactions with antihistamines such as TCA antidepressants, muscle relaxants and anti-seizure medications. Pharmacists should be vigilant and remind elderly patients of the potential drug and disease interactions with chronic use of antihistamines.

2. Liver and cardiac toxicity

Terfenadine, the first non-sedating antihistamine, marketed for allergic rhinitis was withdrawn from the US market in 1997 due to its potential cardiac toxicity, causing arrhythmia and QTc prolongation. This drug also bears a black box warning of causing liver failure when taken together with liver toxic drugs such as ketoconazole. Today, fexofenadine, a metabolite of its parent prodrug terfenadine, has taken its place in the market for similar indication. Though antihistamines in the market today are deemed to be safe, pharmacists should remain vigilant and informed of possible drug-drug interactions and use of certain antihistamines in patients with cardiac conditions as antihistamines with similar chemical structure can cause similar adverse reactions.

3. Therapeutic duplication with combination medications

Self-medication is becoming more popular with the public being more informed of the use of medications. It is also not uncommon to find antihistamines being present alone or in combination with other ingredients in cold and cough medications, and OTC sleep aid products. Many patients today, however, do not read or fail to understand the ingredients in a combination medication, leading to harmful duplication. Pharmacists should stay cautious of patients taking duplicative antihistamines and perform opportunistic counselling to avoid unnecessary adverse reactions due to repeated active ingredients.

A simple request for an antihistamine in the pharmacy can lead to more than meets the eye. While they are safe, easily available and affordable, healthcare professionals should pay attention to patients with specific health conditions. It is also imperative for pharmacists to perform opportunistic counselling to prevent the duplication of active ingredients in combination medications. MIMS