Foundayo, produced by pharmaceutical giant Eli Lilly and Company, represents a major milestone as the first drug of its kind approved through the National Priority Voucher program, a fast-track pathway designed to speed up the review and approval of important treatments.

The drug has been approved — to be used in collaboration with reduced calorie intake and increased physical activity — to help people who are overweight and have related health conditions lose weight and keep it off over time.

RELATED: The Weight Loss Drug Millions Use Just Got an Upgrade. As GLP-1 Use Surges, FDA Clears Stronger Wegovy Dose

Foundayo is also the only GLP-1 weight-loss pill that can be taken at any time of day, without needing to follow food or water restrictions.

Though more research is needed, GLP-1 drugs have also been touted for their ability to reduce cancer risk. The general line of thinking is that several cancers have been linked to obesity — and the drugs have changed the game when it comes to weight management.

What To Know About Foundayo

“People living with obesity need treatment options that meet them where they are — and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment,” Dr. Deborah Horn, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston, said in a press release on the approval.

With Foundayo, she added, there is now an oral option that delivers an average of 12.4% weight loss at the highest dose in clinical trials.

In an effort to make Foundayo an affordable and easily accessible drug, it may be as low as $25 per month for patients with eligible insurance plans. For those wanting to self pay, the drug will cost $149 per month for the lowest dose. Eligible Medicare Part D individuals may be able to purchase the drug for a co-pay of $50 per month starting in July.

With more people having easier access to weight loss drugs like Foundayo, there’s hope for a reduction in obesity-related cancer risk. According to a study released in JAMA, weight loss of more than 10% of overall body weight — whether through bariatric surgery (procedures that reduce stomach size) or GLP‑1 medications like Wegovy or Ozempic — has been linked to modest reductions in obesity‑related cancer risk.

However, researchers say more randomized clinical trials are still needed to confirm the effect.

“GLP‑1s are amazing medications. They change people’s lives in terms of cardiac risk and diabetes. They have widespread benefits,” Dr. Samantha Newman of Memorial Sloan Kettering Cancer Center, previously told SurvivorNet.

Integral to blood sugar control, GLP-1 is a hormone released by the gut as a reaction to food. It causes the pancreas to release insulin. A rising blood insulin level causes all body tissues to absorb glucose (blood sugar) from the bloodstream, lowering blood glucose levels.

GLP-1 also prevents the release of glucagon, a hormone that raises blood sugar levels by stimulating liver cells to release glucose, and helps people feel full for longer. These effects may also cause people to experience weight loss.

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“Some of the benefits for using GLP-1 agonists can be weight loss, improvement in glycemic control or blood glucose, decreased risk of weight-related conditions such as various cancers, like breast cancer, endometrial cancer, colon cancer, liver disease,” Dr. Holly Lofton, director of the Medical Weight Management Program at NYU Langone in Manhattan, told SurvivorNet in an earlier interview.

Potential Side Effects

Although Foundayo’s approval is exciting, it’s important to understand that this drug is not recommended to be taken with other GLP-1 receptor agonist medicines, and it may not be the right choice for all patients struggling with their weight.

RELATED: The Pill Form Of GLP-1 Weight Loss Drugs Is Surging: New Early Data Finds More Urban, White Women Taking Advantage of Expanded Access to the Drug

The drug’s prescribing information notes that Foundayo may cause tumors in the thyroid, including thyroid cancer, and patients are advised to watch for possible symptoms like a lump or swelling in the neck, hoarseness, trouble swallowing or shortness of breath when taking the drug.

The most common side effects associated with Foundayo include:

• Nausea
• Constipation
• Diarrhea
• Vomiting
• Indigestion
• Stomach (abdominal) pain
• Headache
• Swollen belly
• Feeling tired
• Belching
• Heartburn
• Gas
• Hair loss

More serious side effects could include pancreatitis, dehydration that leads to kidney issues or other stomach problems, low blood sugar, vision changes (in people with type 2 diabetes), gallbladder issues, and allergic reaction.

More information can be found in the full Medication Guide.

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Understanding Cancer Risk and Obesity

Recent research published in JAMA indicates that obesity can be linked to roughly 10% of all new cancer diagnoses in the United States each year, and for certain cancers, it may account for up to half of all cases.

The researchers estimate that excess weight contributes to up to 50% of endometrial and hepatobiliary cancers, such as liver, gallbladder, and bile duct. But significant weight loss could reverse these trends.

“One of the biggest takeaways from this paper is that people with classical obesity often need to lose more than 10% of their body weight to meaningfully reduce cancer risk,” Dr. Neil Iyengar, Co-director of Breast Medical Oncology and Director of Cancer Survivorship at Emory Winship Cancer Institute, told SurvivorNet.

“Diet, exercise, and lifestyle changes are essential for maintaining a healthy weight, but reaching that level of weight loss can be incredibly difficult for many. That’s why the discussion also includes tools like GLP‑1 receptor agonists and bariatric surgery, which can help support the kind of significant weight loss associated with lowering cancer risk,” he added.

For years, scientists have warned that carrying excess body weight creates a biological environment where cancer can thrive.

According to the study’s authors, obesity is associated with a higher incidence of cancers, including:

• Endometrial
• Esophageal
• Gastric
• Renal
• Colorectal
• Liver, gallbladder, and bile duct (hepatobiliary cancers)
• Pancreatic
• Prostate
• Postmenopausal breast
• Ovarian
• Thyroid
• Multiple myeloma

Why Exercise Can Decrease a Woman’s Risk of Breast Cancer

While these weight loss drugs have been game-changers when it comes to managing weight, overall healthy lifestyle choices, like staying active and eating a balanced diet, have been shown to reduce cancer risk as well.

The National Cancer Institute analyzed several studies to observe the impact of physical activity on overall cancer risk, noting that “higher levels of physical activity are linked to lower risk of several types of cancer.”

Regular exercise, a balanced diet, and managing stress are some ways people can practice leading a healthy life.

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“Excess weight is one of the most important causes of cancer, second only to smoking, which it may even overtake in the coming years,” Dr. Graham Colditz, Director of the Division of Public Health Sciences at WashU Medicine and Siteman Cancer Center, explained.

“As rates of obesity continue to rise, we need to invest in effective systemic changes to help prevent weight gain and to help with weight loss. This can include better infrastructure that promotes activity, better access to affordable, healthy foods, and insurance that covers weight and diet counseling,” Dr. Colditz added.

Monitor Your Cancer Risk & Keep Up With Recommended Screenings

While weight management is one way to take an active role in reducing cancer risk, keeping up to date with recommended cancer screenings is equally important.

Screening recommendations vary based on age and health history.

Here is a breakdown of current screening guidelines in the U.S. for the most common types of cancer in both men and women:

• Colorectal Cancer: In recent years, the United States Preventative Services Task Force (USPSTF) recommended that the colorectal cancer screening age be lowered to 45; the previous recommended age was 50.
• Breast Cancer: The USPSTF also lowered the recommended age to begin breast cancer screening to 40. The previous guidance issued in 2016 was age 50.
• Lung Cancer: Because of the link between smoking and lung cancer, the USPSTF recommends that adults between ages 50 and 80 who have a 20 pack-year smoking history and currently smoke or have quit within the past 15 years should be screened annually.
• Prostate Cancer: The USPSTF recommends men at average risk between 55 and 69 years old talk with their doctor about the pros and cons of  screening. The American Cancer Society makes slightly different recommendations, suggesting men at average risk begin screening at 50, and men at higher risk at 45 or even 40.

WATCH: How One Cancer Survivor and Her Sister Used “My Health Questions” to Navigate Care 

Questions To Ask Your Doctor

• Am I eligible for the new GLP-1 pill?
• Is there any reason you recommend the injectable form over the pill?
• What potential side effects should I be on the lookout for?
• Are there other weight loss strategies you recommend instead?

Contributing: Survivornet Staff

Learn more about SurvivorNet's rigorous medical review process.

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