Improving immunotherapy for advanced prostate cancer
New Prostate Cancer Treatment Brings Hope To Many
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FDA Approves J&J Combo Drug For Prostate Cancers With Certain Genetic Signature
Advanced prostate cancer has a new treatment option, a Johnson & Johnson drug that combines two of the company's therapies in a single pill.
The FDA approval of the J&J drug, brand name Akeega, covers adults whose cancer has spread and no longer responds to hormone therapies. Crucially, the cancer must also have a BRCA mutation. One of the components of the drug, niraparib, is specifically designed to address this mutation. The FDA also approved a Foundation Medicine companion diagnostic that identifies patients whose cancer has the BRCA mutation.
Niraparib is small molecule designed to block PARP, an enzyme important to the way cancer cells repair DNA damage. Cancers with BRCA mutations are sensitive to drugs that block PARP. Akeega pairs that niraparib with Zytiga, a blockbuster J&J drug that won its first FDA approval in prostate cancer in 2011. Zytiga is a small molecule that leads to blocking of the synthesis of androgens, hormones that support prostate cancer progression. This drug must be administered with prednisone, a corticosteroid.
FDA approval of Akeega is based on the results of a placebo-controlled Phase 3 study. The main goal was to measure radiographic progression-free survival (rPFS), which was defined as the time from randomization to progression of the cancer as shown by imaging, or death, whichever comes first. The results showed that participants with BRCA-positive cancer that was treated with Akeega plus prednisone had a statistically significant 47% risk reduction in rPFS. The most common adverse events reported in the study included muscle pain, fatigue, constipation, hypertension, and nausea.
Akeega won its first regulatory approval in April in the European Union. With the FDA approval, the drug will now compete against two PARP inhibitors that won their U.S. Approvals in June for treating prostate cancers. The AstraZeneca and Merck-partnered drug Lynparza was first, winning a regulatory nod for use in combination with abiraterone. Weeks later, the agency approved Pfizer's PARP-blocker Talzenna for use in combination with Xtandi, a drug that's already a blockbuster prostate cancer therapy for the pharmaceutical giant.
J&J's Janssen subsidiary licensed rights to niraparib from Tesaro, a cancer biotech that GSK acquired in 2019. GSK currently markets the drug as Zejula for treating ovarian cancer. J&J's 2016 deal with Tesaro granted it exclusive global rights, except for Japan, for use of the drug in treating prostate cancer. The approval of Akeega marks the first FDA approval of its PARP-blocking pharmaceutical component for applications in prostate cancer.
"Janssen's legacy of advancing the science of prostate cancer has contributed to the evolution of transformational treatment approaches for more than a decade," Kiran Patel, vice president, clinical development, solid tumors at Janssen Research & Development, said in a prepared statement. "This milestone, which marks the approval of Janssen's third prostate cancer treatment, highlights the importance of advancing precision medicine approaches and genetic testing for the treatment of patients with BRCA-positive [metastatic castration-resistant prostate cancer]."
Public domain image by the National Cancer Institute
Drinking Milk May Put You At Risk For Prostate Cancer
Men who chug milk — or even sip a little — every day would be smart to cut back or even eliminate it from their diets. That's because several recent studies conclude that milk, though not necessarily other dairy products, may put them at higher risk for prostate cancer.
An article published in 2023 in the International Journal of Disease Reversal and Prevention reviewed several large studies linking cancer to dairy consumption and pointed to two possible reasons why milk may increase prostate cancer risk: estrogen and something called insulin-like growth factor 1 (IGF-1), which are hormones produced naturally in cow's milk.
"IGF-1 is a growth hormone, and growth hormones can cause cancers to grow," says Anna Herby, DHSc, RD, nutrition education program manager for the Physicians Committee for Responsible Medicine (PCRM) and corresponding author of the review article.
One of the studies that were reviewed followed nearly 22,000 men for almost three decades, and determined that those who consumed 2.5 servings of dairy daily had a 34 percent higher risk of developing prostate cancer compared with men who consumed half a serving or less. One surprising finding: The study found that low-fat and skim milk brought a higher risk of prostate cancer than regular or high fat milk. Dr. Herby says that may be due to estrogen's ability to "bind" with more watery products (like skim milk).
Even a Small Amount of Milk May Increase Prostate Cancer RiskMerely cutting back on milk might not be enough to reduce your risk: A recent study found that even a little milk in your coffee every day could boost your risk of prostate cancer. The results were published in The American Journal of Clinical Nutrition.
Researchers at Loma Linda University followed the health and self-reported dietary habits of nearly 30,000 men in the United States and Canada over a five-year period. They compared their data with state cancer statistics and concluded that men who consumed 430 grams of dairy per day (about 1 ¾ cups of milk) had a 25 percent higher risk of prostate cancer compared with men who consumed 20 grams of dairy per day (about a tablespoon of milk).
What's more concerning is that even a very small amount of milk may increase prostate cancer risk, according to Gary Fraser, MBChB, PhD, the study's principal investigator and distinguished professor at Loma Linda University School of Medicine and School of Public Health in California.
"The lowest risk of cancer is [seen with] close to zero milk consumption, and the risk increases dramatically up to about three-quarters of a cup of milk a day. But above that level, the risk doesn't continue to increase," he says.
Dr. Fraser cautions that pinpointing the exact risk of cancer from milk, or any food, is challenging because people self-report — and misreport — their consumption, and because there are so many other factors (such as overall diet and lifestyle) that can increase or reduce risk. Still, he believes milk is a real concern for men.
"Our study and a number of other studies raise a very serious question as to whether dairy and milk consumption is related to prostate cancer, and a prudent person may seriously consider reducing consumption or eliminating milk from their diet," he says.
Many Factors Affect Prostate Cancer RiskDiet is just one risk factor for prostate cancer, and having one or more risk factor does not mean you're likely to get cancer. Top risk factors for prostate cancer include but are not limited to:
Should men worry about a higher risk of prostate cancer if they consumed a lot of milk as a child? The answer to that question is unclear, as any study attempting to investigate that would have to follow males for 50 years or more (remember, prostate cancer usually shows up in older men). Herby says that parents who worry about a child's risk of developing prostate cancer much later in life might want to think twice about giving them cow's milk.
"Children can live without dairy, and there are many nondairy products that provide a good source of calcium, including almond milk," she says. "And soy milk, a good source of calcium, has been found to be protective against some types of cancer."
Herby also points to the growing body of research showing that a plant-based, vegan diet (no animal products and no dairy) can further reduce the risk of prostate cancer and other cancers. "We can always use more data on how a fully plant-based diet can reduce the risk of all types of cancer, but I can say avoiding dairy is a good way to go," she says.
Nondairy sources of calcium (including nonvegan foods) include:
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