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FDA Panel Recommends Multi-cancer Detection Blood Test

A Food and Drug Administration (FDA) advisory committee has supported a blood-based multi-cancer detection test as the agency decides whether or not to approve it. Galleri is one of a growing number of liquid biopsies, or tests that examine fluid from the body, most commonly blood. This test analyzes a blood sample to see if it contains DNA fragments that could indicate the person has cancer. If the results suggest potential disease, follow-up testing is required to confirm a diagnosis. The biotechnology company Grail, which manufactures Galleri, claims it can detect up to 50 cancer types, the Washington Post reported. The test is for people 50 and older and is not intended to replace routine cancer screening. Galleri has been sold in the U.S. since 2021, but the FDA has yet to approve the test. This week, the FDA’s Medical Devices Advisory Committee unanimously voted that the test is safe to use. In a 6-4 decision, the panel found Galleri is effective. In a 7-2 vote with one abstention, it decided the test’s benefits outweigh its risks. Proponents of the device say Galleri could offer a noninvasive way to test people for cancers for which no screening options exist. However, even committee members who voted in support of the test acknowledged there is not yet enough data to confirm its clinical benefit. “If we can find more stage I or more early-stage cancers in a population that we can’t screen for currently, then that will end up having benefit,” committee member Victor van Berkel, a thoracic surgeon at UofL Health in Louisville, Kentucky, told the Post. “But I don’t know that that’s been proven yet. So perhaps my ‘yes’ is a hopeful [vote] rather than an accurate one.” Other experts have expressed skepticism about the test, arguing it can produce false positives, which could cause patients unnecessary anxiety, and false negatives, which may give people false reassurance and discourage them from undergoing recommended screening. “People might see this [and think]: ‘Well, I can just go do a one-time test. If it comes back negative, I have no cancers, and I don’t have to do a colonoscopy,’” committee member Emil Lou, a medical oncologist at Masonic Cancer Center in Minneapolis, told the Post. The FDA, which often follows the recommendations of its advisory panels, is reviewing Galleri and is expected to decide whether to approve it in the coming months, the Post reported. The test costs nearly $1,000, but FDA approval could make broader insurance coverage possible.

FDA Approves Targeted Therapy Combination for Breast Cancer

The Food and Drug Administration (FDA) approved a two-drug targeted therapy regimen for certain people with breast cancer that has progressed during or after hormone therapy. The FDA approved Inluriyo (imlunestrant) and Verzenio (abemaciclib) for people with advanced or metastatic estrogen receptor-positive, HER2-negative, ESR1-mutated breast cancer. Patients must first have an ESR1 mutation detected on an FDA-approved test, Healio reported. Inluriyo blocks and degrades estrogen receptors, including ones altered by an ESR1 mutation, which can cause resistance to hormone therapy. Verzenio blocks proteins called CDK4 and CDK6, which help cancer cells divide. The FDA based its approval on results from a phase III clinical trial involving 874 people with advanced or metastatic estrogen receptor-positive, HER2-negative breast cancer that had recurred or progressed despite hormone therapy. Participants received one of three treatments: the drug combination, Inluriyo alone or standard hormone therapy. Among participants with ESR1-mutated disease, people who received the combination regimen had a median progression-free survival of 11.1 months, compared with 5.5 months for those who took Inluriyo alone. “We have an urgent need for effective and safe treatment options for patients with disease progression on adjuvant or first-line therapy,” Komal Jhaveri, the trial’s lead investigator and a breast medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, said in a press release. “Combining therapies that work on two distinct drivers of tumor growth—the estrogen receptor and CDK4/6—is an important strategy to help address treatment resistance.” The FDA approved Inluriyo in September 2025 after earlier results showed the drug extended progression-free survival compared with standard care.

Rare Genetic Mutation May Increase Lung Cancer Risk

A rare genetic mutation is associated with increased risk for lung cancer, according to a study published in Science. Researchers looked at genetic and health data for 3.37 million people in a databank collected by the genetic testing company 23andMe. They found about 1 in every 15,850 people had an EGFR T790M genetic mutation. The mutation was more prevalent in Southern Appalachia, specifically Tennessee and Alabama, where about 1 in every 2,000 people carried the mutation, the study found. People with the mutation who smoked had a 10-times greater risk than smokers who do not carry the mutation, while nonsmokers with the mutation had a 62-times higher risk. The EGFR T790M mutation was not linked to increased risk for any other cancer. First discovered in 2005, this mutation had not been previously analyzed in a large-scale study because it is so rare, the New York Times reported. While EGFR mutations usually develop later in life, EGFR T790M mutations can be inherited and present from birth. The findings prompted experts to question whether people with the EGFR T790M mutation could benefit from screening with a low-dose CT scan, which is currently recommended for current and former heavy smokers ages 50 to 80. Researchers are also investigating what this mutation can teach them about the inner workings of lung cancer. “There’s a lot to learn here,” Pasi A. Jänne, a study author and a medical oncologist at Dana-Farber Cancer Institute in Boston, told the Times.

Mindfulness, Tai Chi Can Reduce Fatigue, Pain in Cancer Survivors

Mindfulness and ancient Chinese mind-body practices helped reduce pain and fatigue in cancer survivors, according to a study published in the Journal of Clinical Oncology. In a clinical trial of 587 people with multiple types of cancer, 170 people participated in a nine-week mindfulness-based cancer recovery program involving meditation and yoga. Meanwhile, 219 people joined an 11-week program that taught them tai chi and qigong, which are ancient Chinese practices that involve gentle movements and deep breathing, and 198 people were waitlisted. At the end of the trial, people who participated in either the mindfulness or tai chi programs reported larger improvements in fatigue and pain scores than those on the waitlist, while people in the tai chi program also reported greater improvement in sleep quality. The study found when participants saw improvement in one area, they tended to see gains in the other two, which may be because sleep quality, fatigue and pain are interrelated, HealthDay reported. Researchers noted the findings highlight how mind-body practices may help survivors manage symptoms that can linger well after treatment ends. “More and more people with cancer are surviving longer term, but often, they are struggling with long-term side effects that can be difficult to manage,” Linda Carlson, the study’s lead author and a clinical psychologist at the University of Calgary in Alberta, said in a press release. “This study highlights that the cancer experience doesn’t just end for survivors after active treatment is done, and we hope it starts a conversation amongst medical teams about how to incorporate these mind-body therapies into overall cancer care.”