The First All-Oral Regimen for AML Is a Game Changer: Karilyn Larkin, MD

The May 13 FDA approval of decitabine and cedazuridine (Inqovi; Taiho) plus venetoclax marks a pivotal shift in how acute myeloid leukemia (AML) is treated—one that carries profound implications not just clinically, but emotionally and logistically for patients. Karilyn Larkin, MD, physician and associate professor of hematology at The Ohio State University Comprehensive Cancer Center–The James, spoke to the significance of moving from intravenous (IV) inpatient treatment to a fully oral regimen patients can take at home.

Not long ago, an AML diagnosis meant an immediate hospital admission, IV chemotherapy, and often a month or more of inpatient care—a reality made even more devastating during the COVID-19 pandemic, when visitors were barred entirely.

“When a patient comes into the hospital and thinks they have the flu or something like that, then they’re told they have this terrible cancer and it’s so aggressive, and they can’t even go home and pack a bag,” Larkin said, “that is a really hard thing for a person to sort of get through."

The availability of an oral therapy that matches the efficacy of IV treatment allows patients to recover at home, surrounded by their support systems—a factor Larkin emphasized as critical to coping. Beyond the emotional toll, she noted the financial burden of prolonged hospitalization is equally significant, encompassing not just direct medical costs but also the logistical strain on caregivers who must take time away from work, arrange transportation, and manage extended absences from daily life.

“You’re not compromising on effectiveness, but you can go home,” she said. “You can go home, and you can take it, and you can manage side effects. It's really pretty awesome."

However, the shift to an all-oral regimen also removes the built-in clinical safety net that comes with infusion center visits—routine vitals checks, lab monitoring, and nursing assessments that happen almost automatically. That burden now falls on patients and caregivers. Larkin stressed that thorough patient education is essential. Patients with AML on oral therapy must understand strict fever protocols during neutropenia, the dangers of masking symptoms with acetaminophen, and when low platelet counts demand immediate attention—knowledge that can be lifesaving outside a clinical setting.