Update: News from the FDA: Colorectal cancer screening and treatment

RELEVANCE

Most relevant for: People with colorectal cancer or at risk of colorectal cancer.

It may also be relevant for:

• people with colorectal cancer

Relevance: Medium-High

Relevance rating details

What is this update about?

This article highlights recent FDA updates related to colorectal cancer (CRC), including:

• Updated educational information about colorectal cancer, including a recommendation to begin screening by age 45.
• Approval of a new form of a drug combination (Opdivo Qvantig) for solid tumors, including colorectal cancer
• Approval of two new drugs for certain colorectal cancers
• Approval of two new screening tests for colorectal cancer (Colosense and Shield) for people with average cancer risk. Colonoscopy remains the recommended screening test for people at high risk of colorectal cancer.

Why is this update important?

Colorectal cancer (CRC) is the third most common cancer worldwide, following lung and breast cancer. It is also the second leading cause of cancer-related deaths. This update highlights how awareness, early detection and preventive measures can help reduce the impact of this disease.

Recent updates show that increased colorectal cancer screenings and decreased smoking have helped reduce CRC cases and deaths in the U.S. As a result, doctors now recommend that people start screening for colorectal cancer at age 45.

Colorectal cancer screening updates

The FDA provides valuable educational information on colorectal cancer (CRC) in an updated fact sheet and emphasizes on its website that CRC is a preventable disease Colorectal Cancer: What You Should Know About Screening.

CRC often starts as growths called polyps in the rectum or colon (large intestine). Detecting and removing these growths or precancers early is crucial, and screening tests are the only way to find them.

While most cases of CRC occur in people over the age of 50, younger adults are now being diagnosed more often. Men are more likely to be diagnosed and die from colorectal cancer than women. While colorectal cancer affects all racial groups, African Americans have the highest risk. African Americans, American Indians and Alaska Natives have higher rates of death from colorectal cancer than white Americans.

People with a family history of CRC have a greater risk of CRC and may need to start screening earlier. For some hereditary cancers, doctors may recommend starting colorectal screening 10 years before the earliest CRC diagnosis in the family.

Given the significant benefits of screening, the FDA recommends beginning colorectal cancer screenings by age 45. If no precancerous changes are found, screenings should be repeated every 10 years.

In Colorectal Cancer: What You Should Know About Screening, the FDA provides an updated list of approved CRC screening methods and a comprehensive guide to the tests and procedures it has reviewed and endorsed. While several screening tests are listed for those with average risk, the FDA recommends colonoscopy for those at high risk.

Risk factors for colorectal cancer

Several factors increase the likelihood of developing CRC, including any of the following:

• a personal or family history of CRC
• an inherited mutation linked to CRC risk (see list here)
• inflammatory bowel disease or other intestinal conditions
• type 2 diabetes
• a sedentary lifestyle
• obesity
• tobacco use
• heavy alcohol consumption (three or more drinks per day)

As with most cancers, the FDA recommends proven lifestyle behaviors to lower the risk of developing CRC, including:

• regular physical activity
• reducing alcohol consumption
• avoiding tobacco
• maintaining a healthy weight

If you experience changes in your bowel movements, unexplained weight loss, pain, cramps, fatigue or other symptoms that are not typical for you, talk with your doctor. Screening allows early detection and greatly improves the chance of successful treatment. Survival rates can reach up to 90% in some instances when CRC is caught early. Additionally, clinical trials for people with colorectal cancer may provide access to cutting-edge treatments and contribute to advances in treatment.

Combined therapy approved as an injection

The FDA approved Opdivo Qvantig for treating dMMR or MSI-H metastatic colorectal cancer that has progressed after standard treatment. Opdivo (nivolumab) is a type of drug known as immunotherapy. In the past, Opdivo was only available as an intravenous (IV) injection. Opdivo Qvantig is a new version of the drug combined with hyaluronidase that can be injected under the skin, which may be more convenient than the previous intravenous (IV) infusion form. Clinical studies show that this injection works as well as IV treatments.

It is important to note that this option has side effects that are similar to the IV form, which can include fatigue, muscle pain, itchy skin or cough. Although rare, serious immune system-mediated side effects may also occur. (For more information about Opdivo side effects, see articles here and here). Additionally, because this is a shot, there can also be local pain, inflammation or bleeding at the injection site, similar to any other skin injection.

Treatment for CRC with KRAS tumor mutations

The KRAS G12C mutation is a specific tumor mutation that is common in certain lung cancers but also occurs in 3 to 4% of colorectal cancers, including those among some people with hereditary colorectal cancer.

The FDA has recently approved the following two combined drug therapies for adults with metastatic colorectal cancer that has a KRAS G21C tumor mutation. Each of these combinations includes one oral (pill) therapy along with an injection/infusion treatment:

1. Lumakras (sotorasib) + Vectibix (panitumumab)
This combination has been shown to stop tumor growth longer than traditional treatment. Based on the CodeBreaK300 study, patients treated with this combination went 5.6 months without their cancer growing, compared to just two months with standard treatment. Common side effects include diarrhea, muscles and joint pain, nausea, fatigue and liver problems.

2. Krazati (adagrasib) + Erbitux (cetuximab)
Based on preliminary data from the KRYSTAL-1 study, the FDA granted accelerated approval for this combined therapy. This combination may improve the chances of tumor shrinkage and slowed cancer growth. Side effects can include rash, nausea, diarrhea, vomiting, fatigue, pain and liver issues.

To be eligible for either combined drug therapy, patients must have previously had chemotherapy treatments that included fluoropyrimidine, oxaliplatin and irinotecan and have a metastatic colorectal cancer that has the KRAS G12C mutation.

The FDA approved two new tests for screening healthy adults for colorectal cancer: the Colosense and Shield tests.

• The ColoSense test detects early signs of colorectal cancer and precancerous growths from a stool sample, which you can collect at home and send to a laboratory for testing. The results are forwarded to your healthcare provider for review.
• The Shield test is a blood test that detects DNA mutations within the blood cells that may indicate the presence of cancer: 
  • In a clinical study, the Shield test found 83% of cancers, although it also had a 17% false negative rate, meaning it failed to detect 17% of colorectal cancers among participants.
  • The test had about a 10% false positive rate, meaning about 10% of study participants were told they had cancer when they did not.

Both tests are intended for adults aged 45 and older who have an average risk of colorectal cancer. Average risk means no personal or immediate family history of colorectal cancer, colon polyps or inflammatory bowel disease. Speak with your doctor if you are unsure whether you qualify for screening as an average risk individual. These tests are less invasive than a colonoscopy but are not a replacement. A positive test result requires further evaluation, usually by colonoscopy.  

A negative result does not rule out the possibility of colorectal cancer or precancerous adenomas (polyps), so ongoing screening by colonoscopy is recommended. These new tests may be most useful for people who need screening between colonoscopies and or have difficulty tolerating a colonoscopy.

Neither of these tests is approved for those at high risk of CRC, which can include those with a strong family history of the disease or an inherited mutation.

What does this mean for me?

The FDA updates in this article share the increased screening and treatment options that help detect and address colorectal cancer early.

• Understanding Risk: If you’re concerned about your colorectal cancer risk, the FDA has educational materials to answer key questions. FORCE has information about hereditary colorectal cancer risk (linked here).
• Treatments:
  • If you have dMMR or MSI-H metastatic colorectal cancer, you may be eligible for treatment with Opdivo Qvantig injections.
  • If you have colorectal cancer with a KRAS G21C tumor mutation, two new combined drug therapies may benefit you: Lumakras (sotorasib) + Vectibix (panitumumab) or Krazati (adagrasib)+ Eribitux (cetuximab).
• New Screening Options: The ColoSense stool test and Shield blood test are two new ways to detect colorectal cancer in people at average risk of colorectal cancer. However, the FDA states that these tests should not be used for people at high risk who still need a colonoscopy. These tests can miss some colorectal cancers or precancerous adenomas that may occur more often among those at high risk.

If you have symptoms or concerns, talk to your doctor about the best screening and treatment options.

Reference

U.S. Food and Drug Administration. Colorectal cancer: What you should know about screening. U.S. FDA. Updated March 28, 2024. Accessed March 7, 2025.

U.S. Food and Drug Administration. Colorectal cancer. U.S. FDA. Updated April 1, 2024. Accessed March 7, 2025.

U.S. Food and Drug Administration. FDA approves sotorasib and panitumumab for KRAS G12C-mutated colorectal cancer. U.S. FDA. Published January 16, 2025. Accessed March 7, 2025.

U.S. Food and Drug Administration. FDA grants accelerated approval to adagrasib and cetuximab for KRAS G12C-mutated colorectal cancer. U.S. FDA. Published June 21, 2024. Accessed March 7, 2025.

U.S. Food and Drug Administration. FDA approves nivolumab and hyaluronidase-nvhy for subcutaneous injection. U.S. FDA. Published December 27, 2024. Accessed March 7, 2025.

U.S. Food and Drug Administration. Shield (P230009). U.S. FDA. Published October 8, 2024. Accessed March 11, 2025.

U.S. Food and Drug Administration. ColoSense (P230001). U.S. FDA. Published August 27, 2024. Accessed March 11, 2025.

Disclosure: FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

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posted 4/16/25