The Food and Drug Administration approved daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients ineligible for stem cell transplant on January 27, 2026. The approval expands treatment options for a significant subset of myeloma patients who cannot undergo the standard autologous stem cell transplant procedure.
This approval follows a period of substantial activity in oncology drug approvals. The FDA authorized 20 fresh cancer treatments in the final quarter of 2025 alone, bringing the total for the year to over 50, according to the American Association for Cancer Research. These approvals span a range of cancer types, including lung cancer and multiple myeloma.
Recent advancements also include expanded uses for menin inhibitors, a relatively new class of cancer drugs. Revumenib, initially approved over a year ago, now has an expanded indication for treating acute myeloid leukemia (AML) in patients as young as one year old who have relapsed or are refractory to treatment and lack alternative options. Ziftomenib received its first FDA approval for adult patients with relapsed or refractory AML harboring a susceptible NPM1 mutation, also when other treatments have failed.
Both revumenib and ziftomenib target the menin protein, which plays a role in cancer-promoting gene expression when complexed with MLL1. Mutations in nucleophosmin 1 (NPM1) can enhance this process, making it a key target for these inhibitors. Research published in the AACR journal Cancer Discovery details the mechanism by which mutated NPM1 interacts with the menin-MLL1 complex.
The FDA maintains a listing of cancer-related accelerated approvals that require ongoing clinical trials to verify long-term clinical benefit. This ongoing monitoring is a standard component of the accelerated approval process, ensuring continued evaluation of new therapies.
