January Roundup of FDA Approvals in Oncology: Decisions to Know

Below is your guide to all the oncologic options that were cleared by the FDA in January 2026. The regulatory roundup provides everything you need to know, right at your fingertips—all the topline findings that supported the decisions and expert insights detailing clinical practice implications.

1/27: FDA Approves Daratumumab and Hyaluronidase Plus VRd for Newly Diagnosed Multiple Myeloma

Indication: The FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant (ASCT).¹

Supporting data: The decision was based on data from the phase 3 CEPHEUS trial (NCT03652064), which showed higher minimal residual disease (MRD) negativity rates with daratumumab plus VRd vs VRd alone, at 52.3% vs 34.8% (P = .0005). The daratumumab-based quadruplet also significantly improved progression-free survival (PFS), with median PFS not reached in either arm and a hazard ratio of 0.60 (95% CI, 0.41-0.88; P = .0078), supporting deeper and more durable responses.

Clinical significance: This approval expands the use of anti-CD38–based quadruplet therapy into the transplant-ineligible newly diagnosed setting, providing a more effective frontline option for appropriate patients. By achieving higher rates of MRD negativity and improving PFS, daratumumab plus VRd reinforces quadruplet regimens as a new standard of care for select patients with newly diagnosed multiple myeloma who cannot undergo ASCT.

In a recent exclusive interview with OncLive®, Marc J. Braunstein, MD, PhD, spotlighted the clinical implications of this decision. Braunstein is an associate professor in the Department of Medicine and codirector of the Hematology-Oncology System at the New York University Grossman Long Island School of Medicine.²

OTHER RELATED COVERAGE

• “[Treatment selection] comes down to tailoring the various options we have to patients’ various features. For an older patient, you can get a very meaningful PFS benefit while sustaining a good quality of life during that time with either [a triplet or quadruplet],” Braunstein said in a Q&A.³ “However, with quadruplet-based regimens that include a monoclonal antibody, the PFS is superior.”
• Data from the phase 3 PERSEUS (NCT03710603) and CEPHEUS trials (NCT03652064) shared during the 22nd Annual International Myeloma Society Meeting and Exposition indicated that achievement of MRD negativity after D-VRd was linked with positive patient-reported outcomes and exposure-adjusted safety outcomes in patients with newly diagnosed multiple myeloma.⁴
• Another post-hoc analysis of the phase 3 CEPHEUS (NCT03652064) and MAIA (NCT02252172) trials showed that treatment with daratumumab-based regimens was linked with clinical benefit vs the respective control regimens in patients with newly diagnosed, transplant-ineligible multiple myeloma, regardless of changes in frailty status.⁵
• Findings from a post-hoc subgroup analysis of CEPHEUS shared during the 2025 ASCO Annual Meeting showed that D-VRd resulted in deeper and more durable responses that translated into improved PFS vs VRd alone in transplant-ineligible patients with newly diagnosed multiple myeloma.⁶
• In a recent Peer Exchange,⁷ a panel of experts walked through the subgroup analyses from CEPHEUS that were reported during the 2025 ASCO Annual Meeting, trial updates on daratumumab-based regimens for transplant-ineligible patients with high-risk cytogenetics, and other subgroup analyses on transplant-ineligible patients with newly diagnosed disease.

1/28: FDA Approves Larger Vial Size for Nelarabine Injection in T-ALL and T-LBL

Indication: The FDA cleared a larger 375-mg/75-mL vial size of nelarabine injection (SH-111) for use in adult and pediatric patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL). Nelarabine is indicated for those with relapsed or refractory disease after at least 2 prior chemotherapy regimens.⁸

Supporting data: This decision represents a second FDA-approved vial size for the same nelarabine formulation, after the previously approved 250-mg/50-mL vial. Nelarabine’s original approval was supported by data pertaining to complete response (CR) rates observed in key adult and pediatric studies, in which CR (including CRs without hematologic recovery) rates ranged from approximately 21% to 23% in heavily pretreated T-ALL/T-LBL populations. No randomized trials showcasing a survival benefit have been conducted.

Clinical significance: The larger vial size was introduced to help address drug shortages and improve dosing flexibility, particularly for pediatric patients, while allowing higher-dose options and reduced waste in adult treatment settings. This decision enhances pharmacy workflow efficiency and dosing precision without changing the established efficacy or safety profile of nelarabine in relapsed or refractory T-ALL/T-LBL.

OTHER RELATED COVERAGE

In March 2023, the FDA cleared SH-111 for use in patients with T-ALL and T-LBL, providing patients with an alternative to a treatment that has historically been in shortage.⁹

Other Noteworthy Decisions

• The FDA has granted accelerated approval to the Guardant360 CDx as a companion diagnostic to identify patients with BRAF V600E–mutant metastatic colorectal cancer who may benefit from treatment with encorafenib (Braftovi) in combination with cetuximab (Erbitux) and chemotherapy.¹⁰

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References

1. FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma. FDA. January 27, 2026. Accessed February 9, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daratumumab-and-hyaluronidase-fihj-bortezomib-lenalidomide-and-dexamethasone-newly
2. Braunstein MJ. Dr Braunstein on the FDA approval of subcutaneous daratumumab with VRd for newly diagnosed multiple myeloma. OncLive.com. January 27, 2026. Accessed February 9, 2026. https://www.onclive.com/view/dr-braunstein-on-the-fda-approval-of-subcutaneous-daratumumab-with-vrd-for-newly-diagnosed-multiple-myeloma
3. Ryan C. SC daratumumab plus VRd expands options in newly diagnosed, transplant-ineligible myeloma: Q&A with Marc J. Braunstein, MD, PhD. OncLive.com. February 2, 2026. Accessed February 9, 2026. https://www.onclive.com/view/sc-daratumumab-plus-vrd-expands-options-in-newly-diagnosed-transplant-ineligible-myeloma
4. San Miguel J, Usmani SZ, Zweegman S, et al. Patient-reported outcomes (PROs) and safety in patients (pts) with NDMM achieving MRD negativity and ≥CR (MRDneg) in the phase 3 PERSEUS and CEPHEUS trials. Presented at: 22nd Annual International Myeloma Society Meeting and Exposition; September 17-20, 2025; Toronto, Canada. Abstract OA-70.
5. Mian H, Facon T, Cook G, et al. Dynamic frailty analysis of transplant-ineligible patients with NDMM in the phase 3 MAIA and CEPHEUS trials of daratumumab + lenalidomide-dexamethasone and bortezomib-RD. Presented at: 22nd Annual International Myeloma Society Meeting and Exposition; September 17-20, 2025; Toronto, Canada. Abstract OA-21.
6. Facon T, Zweegman S, Hungria V, et al. Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study. J Clin Oncol. 2025;43(suppl 16):7516. doi:10.1200/JCO.2025.43.16_suppl.7516
7. Lonial S, Rossi A, Nooka AK, and Rodriguez C. Expert insights on an evolving treatment landscape in multiple myeloma: Updates from EHA 2025. OncLive.com. June 30, 2025. Accessed February 9, 2026. https://www.onclive.com/peer-exchange/expert-insights-on-an-evolving-treatment-landscape-in-multiple-myeloma-updates-from-eha-2025
8. Shorla Oncology announces U.S. FDA approval of larger vial size for nelarabine intravenous administration for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. News release. Shorla Oncology. January 28, 2026. Accessed February 9, 2026. https://www.businesswire.com/news/home/20260127385856/en/Shorla-Oncology-Announces-U.S.-FDA-Approval-of-Larger-Vial-Size-for-Nelarabine-Intravenous-Administration-for-the-Treatment-of-T-cell-Acute-Lymphoblastic-Leukemia-and-T-cell-Lymphoblastic-Lymphoma
9. Shorla Oncology announces U.S. FDA approval of nelarabine injection for the treatment of T-cell leukemia. News release. Shorla Oncology. March 9, 2023. Accessed February 9, 2026. https://shorlaoncology.com/shorla-oncology-announces-u-s-fda-approval-of-nelarabine-injection-for-the-treatment-of-t-cell-leukemia/
10. Guardant Health receives FDA approval for Guardant360 CDx as companion diagnostic for Braftovi (encorafenib) combination in patients with BRAF V600E–mutant metastatic colorectal cancer.News release. Guardant Health. January 22, 2026. Accessed February 9, 2026. https://investors.guardanthealth.com/press-releases/press-releases/2026/Guardant-Health-Receives-FDA-Approval-for-Guardant360-CDx-as-Companion-Diagnostic-for-BRAFTOVI-encorafenib-Combination-in-Patients-with-BRAF-V600E-Mutant-Metastatic-Colorectal-Cancer/default.aspx