{"id":10192,"date":"2026-08-19T09:08:05","date_gmt":"2026-08-19T09:08:05","guid":{"rendered":"https:\/\/relocationtimess.com\/?p=10192"},"modified":"2026-08-19T09:08:05","modified_gmt":"2026-08-19T09:08:05","slug":"how-much-of-a-cancer-drug-is-too-much-patients-researchers-challenge-fda-approved-dosages","status":"publish","type":"post","link":"https:\/\/relocationtimess.com\/?p=10192","title":{"rendered":"How much of a cancer drug is too much? Patients, researchers challenge FDA-approved dosages"},"content":{"rendered":"
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\n Northwestern University economist Chuck Manski studies decision-making amid uncertainty. That prepared him better than many other cancer patients to decide whether to stay on an immunotherapy treatment that was making him very ill.\n <\/p>

Read more The \u2018world\u2019s first rewilded sharks\u2019 are being raised by shark nannies<\/a><\/p>\n

\n For six months in 2022, Manski received monthly infusions of nivolumab to fight advanced melanoma. The drug ruined his thyroid gland, he said, requiring him to go on a special medication for the rest of his life, and caused severe dryness in his eyes, lips, and mouth. The Food and Drug Administration\u2019s protocol for the drug called for an entire year of treatment, but Manski said his oncologist couldn\u2019t explain why. It\u2019s FDA-approved, \u201cso that\u2019s what we use,\u201d she said.\n <\/p>\n

\n By that point, Manski showed no cancer signs or symptoms, and after reading a lot of medical journal articles, he concluded that the intense side effects probably meant the treatment had done about all it could do.\n <\/p>\n

\n \u201cShe couldn\u2019t tell me a year was the optimal dose. Nobody could,\u201d he said, in a June interview from Spain, where he received an award for his economics work. \u201cSo I made my own diagnosis. I took myself off.\u201d\n <\/p>\n

\n Manski\u2019s decision was in line with what doctors in , Israel, Sweden, and other countries were already doing: giving lower doses of nivolumab, sold under the brand name Opdivo, and of a similar drug, pembrolizumab (Keytruda), or giving them for shorter periods or over longer intervals than the FDA recommended. In India, oncologists found that as little as one-twelfth of the labeled dosage of nivolumab had a powerful impact on several cancers.\n <\/p>\n

\n \u201cThere is incredible uncertainty in drug dosing,\u201d Manski said.\n <\/p>\n

\n His experience impelled him to join an informal yet determined community of researchers, doctors, and patients pushing for extra studies to help patients and doctors find the right dosage for an array of cancer drugs. They point to evidence suggesting that taking smaller doses of some cancer drugs, or remaining on them for shorter periods, could save billions of dollars and prevent some of the worst side effects.\n <\/p>\n

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\nChuck Manski’s research, focused on how people deal with conditions of uncertainty, helped him decide whether to stay on a melanoma treatment after it caused severe side effects.<\/span>\n<\/div>\n
Taylor Glascock for KFF Health News<\/figcaption>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

\n In a recent KFF survey, 43% of U.S. adults said they had skipped their medication in the past year because of cost. A Vanderbilt University study of Medicare enrollees released in 2022 found that 30% of cancer drug prescriptions went unfilled at the pharmacy.\n <\/p>\n

\n But dose-optimization studies rarely occur after the early stages of a drug\u2019s development, or once it\u2019s on the market. By then, few parties in the U.S. healthcare system \u2014 beyond patients \u2014 have a stake in learning that a lower dosage could work as well while causing less harm.\n <\/p>\n

\n Pharmaceutical companies have shown little interest in dialing back recommended dosages. Once they set the price for a drug, the more sales, the more profit. One study that examined 29 expensive cancer drugs estimated that if minimum necessary dosages had been used in 2024, the U.S. healthcare system could have saved roughly $31 billion.\n <\/p>\n

\n \u201cDecisions aren\u2019t always made with the best needs of the patients in mind. The bottom line is another reason,\u201d said Matthew Goetz, a breast cancer researcher at the Mayo Clinic Comprehensive Cancer Center.\n <\/p>\n

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\nExperimental pill may become \u2018new standard\u2019 for pancreatic cancer<\/span>\n<\/p>\n<\/div>\n<\/section>\n<\/div>\n

\n Merck last year sold nearly $32 billion worth of pembrolizumab, a drug that\u2019s FDA-approved for more than 40 cancer conditions. It accounted for almost half of Merck\u2019s drug sales. Bristol Myers Squibb, meanwhile, brought in $10 billion from nivolumab, which works similarly to pembrolizumab in tweaking the immune system. Three important but often toxic breast cancer drugs \u2014 Ibrance, Verzenio, and Kisqali \u2014 boosted revenue at Pfizer, Eli Lilly, and Novartis by $4.1 billion, $5.7 billion, and $4.8 billion, respectively.\n <\/p>\n

\n Pembrolizumab is usually prescribed at a fixed dosage; nivolumab is sometimes prescribed at a fixed dosage, sometimes based on the patient\u2019s weight. If the patient is dosed less than what\u2019s on the label, drugmakers generally get less money. And they aren\u2019t the only ones who lose out.\n <\/p>\n

\n Through a federal program known as 340B, created in 1992 to subsidize the treatment of low-income patients, hospitals that treat a certain percentage of low-income patients can buy drugs at a steep discount, while charging insurers or patients more. For Medicare patients, doctors are paid an additional 6% of the drug\u2019s average price for each infusion.\n <\/p>\n

\n From 2010 to 2024, cancer drug revenue to doctors and hospitals increased from about $9 billion to nearly $36 billion, according to research by Aaron Mitchell of the Memorial Sloan Kettering Cancer Center. About half those profits came from immunotherapy drugs like pembrolizumab and nivolumab.\n <\/p>\n

\n \u201cPembrolizumab is the lifeblood of American hospitals,\u201d said Mark Ratain, a professor of medicine and chief hospital pharmacologist at University of Chicago Medicine. \u201cThat\u2019s why you don\u2019t see hospitals in this country running to do trials that test lower doses.\u201d\n <\/p>\n

\n Merck spokesperson Julie Cunningham said the drug\u2019s dosage recommendations were based on extensive testing. \u201cIn a life-threatening and challenging disease such as cancer, it is critical that the dosing for a cancer therapy is established through well-designed clinical trials,\u201d she said. \u201cChanges in dose or duration that have not been similarly studied may potentially compromise the therapeutic effect.\u201d\n <\/p>\n

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\nJuliette Lesko has been battling cancer for two years. A clinical trial her family was hoping to place her in has stopped accepting new patients, following federal funding cuts.<\/span>\n<\/div>\n
CNN<\/figcaption>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
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\n\u2018The rug has been pulled out from under us\u2019: Cancer research funding turmoil leaves families scrambling<\/span>\n<\/p>\n

7 min read<\/div>\n<\/div>\n<\/section>\n<\/div>\n

\n Still, some oncologists start their patients off slowly on any of a variety of cancer drugs, although there may be concerns about lawsuits by a patient or their survivors over a prescription of lower-than-labeled dosages.\n <\/p>\n

\n Kathy Miller, a professor of oncology at the Indiana University School of Medicine, routinely starts metastatic breast cancer patients with 400 milligrams of Kisqali daily for three weeks (with one week off), rather than the 600 milligrams recommended on the label. Sometimes patients ask for the standard dosage.\n <\/p>\n

\n \u201cI have to tell them, \u2018I don\u2019t want to kill you,\u2019\u201d she said.\n <\/p>\n

\n Insurers routinely challenge her lower-dosage prescriptions, Miller said, presumably because price rebates from the drug company are set to the standard dosage. To avoid endless phone battles with insurers, she prescribes 600 milligrams but tells her patients to take only two of the 200-mg pills and save the third for the next cycle.\n <\/p>\n

\n Follow the cures \u2014 and the money\n<\/h2>\n

\n On May 31, at the annual meeting of the American Society of Clinical Oncology, or ASCO, at Chicago\u2019s McCormick Place convention center, most of the audience of 8,000 rose in a prolonged standing ovation for the experimental drug daraxonrasib. Patients with pancreatic cancer who took the drug, according to the study presented that day, lived nearly twice as long \u2014 a median of 13 months \u2014 as those receiving chemotherapy.\n <\/p>\n

\n The next day, in a slightly smaller hall, Amol Patel, a medical oncologist from New Delhi, discussed studies in various cancers in which 20- or 40-mg doses of nivolumab biweekly \u2014 one-sixth or one-twelfth the recommended dosage \u2014 gave Indian patients several months to a year longer survival than patients who underwent chemotherapy, and with fewer side effects.\n <\/p>\n

\n Fewer than 100 people attended Patel\u2019s talk.\n <\/p>\n

\n The ingenious development of daraxonrasib was big news, since pancreatic cancer has been a death sentence until now. But from a global perspective, the news out of India might be just as important.\n <\/p>\n

\n At the ASCO meeting, \u201cthe focus is always on the shiny new drug,\u201d said Daniel Goldstein, an oncologist and drug policy researcher at the Rabin Medical Center in Israel who has fought for a decade, with some success, to lower pembrolizumab dosages in hospitals there and in other countries. \u201cIt can be quite lonely to be us,\u201d he said, adding that he\u2019s seen increasing appreciation of his work.\n <\/p>\n

\n The data from India offered a glimpse of what could be. However, the studies Patel referred to compared ultralow-dosage immunotherapy to older chemo drugs; none compared ultralow doses against standard nivolumab or pembrolizumab treatments. In India, this would be a sterile exercise, because full-dose treatments are beyond the reach of any but the very wealthy, said Vanita Noronha, an oncologist at Tata Memorial Hospital in Mumbai.\n <\/p>\n

\n Bristol Myers Squibb, or BMS, has a program to make its drugs available in lower-income countries. But the company hasn\u2019t been involved in the lower-dose nivolumab trials and, in a statement to KFF Health News, said the evidence suggested that nivolumab at a lower dosage or shorter duration harmed patients.\n <\/p>

Read more Why Ossoff\u2019s savage lampooning of Trump is taking off<\/a><\/p>\n

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\nThe price of remission<\/span>\n<\/p>\n

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\n While not all U.S. oncologists agree with BMS\u2019 assertion, the Indian data is, to most, a mere curiosity. \u201cCan we really give 20 milligrams as opposed to 240?\u201d asked Jessica Bauman of the Fox Chase Cancer Center in Philadelphia. \u201cThe only way we know for sure is a randomized study between the low dose and the highest.\u201d\n <\/p>\n

\n And such trials are unlikely to occur. That means only poorer countries are going to host \u201cthis groundbreaking research,\u201d said Ratain, who is also a cancer doctor at the University of Chicago Medical Center. \u201cThe Indians may have better immunotherapy than we do.\u201d\n <\/p>\n

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\nMark Ratain, a University of Chicago oncologist and clinical pharmacologist, at his Chicago home. Ratain battles what he sees as unnecessarily high dosages of high-cost cancer drugs such as Keytruda and Opdivo.<\/span>\n<\/div>\n
Taylor Glascock for KFF Health News<\/figcaption>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n

\n Clinicians in Europe, where maximizing healthcare dollars has long been a priority, have taken a middle course, studying lower, but not ultralow, doses of immunotherapy.\n <\/p>\n

\n Pulmonologist Michel van den Heuvel at Utrecht University is leading a study comparing the standard nivolumab dosage for lung cancer patients with one that is as much as 50% lower. He also considered giving the low doses half as frequently, but that would have raised ethical concerns and led to a more cumbersome research protocol, van den Heuvel said.\n <\/p>\n

\n In the United States, researchers led by a group at the Dana-Farber Cancer Institute are taking another tack: evaluating whether patients who\u2019ve done well on 27 weeks of pembrolizumab can stop taking it, rather than doing the additional six months per FDA protocol.\n <\/p>\n

\n At the Veterans Health Administration, which has more leeway in testing money-saving medical procedures, doctors saved $1.5 million, about 10% of the previous pembrolizumab cost, over two years at three Veterans Affairs hospitals where they implemented a pilot program to dose patients less frequently, said Garth Strohbehn, a University of Michigan oncologist who also works at the VA.\n <\/p>\n

\n It saves money and requires fewer visits for veterans who often live hours from the hospital, he said. \u201cIt also helps other patients because it opens more slots for infusion.\u201d\n <\/p>\n

\n Julie Gralow, ASCO\u2019s executive vice president and chief medical officer, has made testing dosage a priority. She\u2019s working with scientists in India on an ambitious clinical trial to compare standard nivolumab with four lower dosage levels.\n <\/p>\n

\n She\u2019s also leading an $11 million trial, supported by the federally funded Patient-Centered Outcomes Research Institute, to see whether breast cancer patients can be effectively started on lower doses of the drugs Kisqali and Ibrance, which, along with Verzenio, are in a class of key breast cancer drugs known as CDK4\/6 inhibitors.\n <\/p>\n

\n \u201cWe want to maintain efficacy. But we also want patients to have excellent quality of life,\u201d she said. Especially for patients with advanced cancers, where absolute cure is unlikely, \u201cit\u2019s our job to make sure we\u2019re not compromising quality of life with higher doses that are unnecessary.\u201d\n <\/p>\n

\n In 2021, at Ratain\u2019s urging, Richard Pazdur, who led the FDA\u2019s cancer drug division for many years, launched Project Optimus, intended to get companies to conduct dosing studies that are more precise before launching the large clinical trials they use to obtain FDA approval for new drugs.\n <\/p>\n

\n The agency issued nonbinding guidelines for dosing studies in 2024 and has incorporated Project Optimus principles into the approval process for new cancer drugs, said Health and Human Services spokesperson Emily Hilliard. For example, two dosing regimens were evaluated for each of four lung cancer drugs (fam-trastuzumab deruxtecan, tarlatamab, zongertinib, sunvozertinib), and the lower dose with fewer toxicities was approved in each case, she said.\n <\/p>\n

\n The FDA usually can\u2019t compel a drugmaker to conduct dose-ranging studies after a drug\u2019s approval, Hilliard noted. And by law the agency does not influence drug pricing, she said.\n <\/p>\n

\n Future drugs should have better dosage information, Bauman said, but \u201cnewer drugs will probably be just as expensive at lower doses.\u201d\n <\/p>\n

\n Financial toxicity\n<\/h2>\n

\n Verzenio\u2019s side effects made Allegra Warfield feel so sick, tired, and bewildered, she said, that she considered suicide. She switched to Kisqali, which was tolerable until last September, when coverage of the drug stopped despite her monthly premium payment of $6,000. The cash price for Kisqali was at least $16,000 a month.\n <\/p>\n

\n After fighting her insurer for three months, Warfield, 42, sold her house and belongings in Palm Desert, California, and moved with her fianc\u00e9 to Durham, North Carolina, where they\u2019d found what they considered a reasonable insurance plan.\n <\/p>\n

\n The cancer, the side effects, and the unpayable bills were bad enough. The lack of good answers for her treatment made everything worse, she said.\n <\/p>\n

\n \u201cI was left to research these medications on Facebook and Reddit. The only people talking about the daily reality of these drugs were other patients,\u201d she said. \u201cBut I wanted the studies. I wanted practical guidance.\u201d\n <\/p>\n

\n Stories like these launched a new life mission for Kelly Shanahan, who was an OB-GYN in South Lake Tahoe, California, until side effects from a breast cancer drug caused her to lose sensation in her hands. Unable to practice medicine, Shanahan became a patient advocate who works with a group called the Patient-Centered Dosing Initiative. In 2021, Shanahan developed profound fatigue (\u201cworse than caring for a newborn baby while being on call in my solo practice\u201d) within a few weeks of going on Ibrance. Lowering the dosage caused her worst symptoms to lift, she said.\n <\/p>\n

\n After gathering countless anecdotes, her group has approached drug companies seeking data \u2014 so far with little success \u2014 that might indicate what percentage of patients have needed dosage reductions, and how they fare on lower doses.\n <\/p>\n

\n \u201cIf going down two dose levels cuts effectiveness by 50%, patients need to know that while making decisions. If it doesn\u2019t, they need to know that,\u201d Shanahan said \u2014 even if it means \u201cthe companies won\u2019t make as much money.\u201d\n <\/p>\n

\n Shanahan suggested the data could be found in clinical trials and post-market studies. But if drug companies won\u2019t provide the necessary studies, Manski said, governments should.\n <\/p>\n

\n \u201cThe knowledge to be gained is a common good,\u201d he said.\n <\/p>\n

\nHas an insurance company or pharmacy benefit manager refused to cover a drug an oncologist recommended or prescribed for you or a loved one because the cancer is unusual or rare and lacks clear guidelines? <\/em>Click here<\/em> to contact KFF Health News\u2019 reporting team.<\/em>\n<\/p>\n

\nKFF Health News<\/em> is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at <\/em>KFF<\/em> \u2014 the independent source for health policy research, polling, and journalism.<\/em>\n<\/p>

Read more Sen. Darline Graham admits in debate: \u2018National security is not my thing\u2019<\/a><\/p>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"

Patients and researchers point to evidence that many cancer drug dosages are excessive, and that reducing the amount and frequency could save billions of dollars and prevent some of the worst side effects.<\/p>\n","protected":false},"author":1,"featured_media":10181,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-10192","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health"],"yoast_head":"\nHow much of a cancer drug is too much? 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