OncLive’s FDA Approval Report: The Regulatory Rundown for January 2025

Below is your guide to all of the oncologic therapeutic options cleared by the FDA in January 2025. The roundup provides everything you need to know, right at your fingertips—all the topline findings that supported the decisions and expert insights detailing what they mean for clinical practice.

1/16: Acalabrutinib Plus Bendamustine/Rituximab in Previously Untreated MCL

The combination comprised of acalabrutinib (Calquence), bendamustine, and rituximab (Rituxan; BR) has been approved for use in adult patients with previously untreated mantle cell lymphoma(MCL)who are not candidates for autologous hematopoietic stem cell transplantation based on findings from the phase 3 ECHO trial (NCT02972840). The acalabrutinib combination (n = 299) led to a significant 27% reduction in the risk of disease progression or death vs BR alone (n = 299; HR, 0.73; 95% CI, 0.57-0.94; P = .016).

“Managing this aggressive cancer requires maximizing efficacy while maintaining tolerability, especially for elderly patients,” Michael Wang, MD, Puddin Clarke Endowed Professor, director of Mantle Cell Lymphoma Program of Excellence at the University of Texas MD Anderson Cancer Center, and principal investigator of ECHO, stated in a news release. “Results from the pivotal ECHO trial highlight the promise of the acalabrutinib combination in defining a new standard of care, with [this] approval underscoring the transformative potential of this regimen as a first-line treatment for older patients with MCL.”

Full Approval Also Granted to: Acalabrutinib Monotherapy in Previously Treated MCL

Previously, in October 2017, the FDA granted accelerated approval to acalabrutinib monotherapy for the treatment of adult patients with MCL after at least 1 previous therapy based on findings from the phase 2 ACE-LY-004 study (NCT02213926). The agent elicited an objective response rate (ORR) of 81% (95% CI, 73%-87%), which comprised a complete response rate of 40% and a partial response rate of 41%.

1/16: Sotorasib Plus Panitumumab in KRAS G12C–Mutated Colorectal Cancer

On the same day, the FDA cleared sotorasib (Lumakras) paired with panitumumab (Vectibix) for use in adult patients with KRAS G12C–mutated metastatic colorectal cancer (CRC) who had prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. When sotorasib was administered at a 960 mg daily dose plus panitumumab (n = 53), it led to a 52% reduction in the risk of disease progression or death vs standard-of-care trifluridine/tipiracil (Lonsurf) or regorafenib (Stivarga; n = 54; HR, 0.48; 95% CI, 0.3-7.8; 2-sided P = .005), according to data from the phase 3 CodeBreaK 300 study (NCT05198934).

In a recent interview with OncLive®, Marwan G. Fakih, MD, professor in the Department of Medical Oncology & Therapeutics Research, associate director of Clinical Sciences, medical director of Briskin Center for Clinical Research, division chief of GI Medical Oncology, and co-director of the Gastrointestinal Cancer Program at City of Hope, in Duarte, California, shed light on the approval.

1/17: Datopotamab Deruxtecan in Unresectable or Metastatic HR+/HER2– Breast Cancer

The regulatory agency gave the green light to datopotamab deruxtecan-dlnk (Datroway) for use in adult patients with unresectable or metastatic, hormone receptor–positive, HER2-negative breast cancer who have previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease. The decision was based by data from the phase 3 TROPION-Breast 01 trial (NCT05104866) in which the antibody-drug conjugate (ADC; n = 365) led to a 37% reduction in the risk of disease progression or death vs chemotherapy (n = 367; HR, 0.63; 95% CI, 0.52-0.76; 2-sided P < .0001).

“The approval of datopotamab deruxtecan, a novel TROP2-directed ADC, marks a major therapeutic milestone and provides patients with metastatic breast cancer a new treatment alternative to conventional chemotherapy,” Aditya Bardia, MD, MPH, program director of breast oncology, director of Translational Research Integration at the UCLA Health Jonsson Comprehensive Cancer Center, and global principal investigator for the study, stated in a news release.

He further discussed the significance of the decision in a recent interview:

1/27: Trastuzumab Deruxtecan in Pretreated HER2-Low and -Ultralow Metastatic Breast Cancer

The FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adult patients with unresectable or metastatic, hormone receptor–positive, HER2-low or -ultralow breast cancer that has progressed on 1 or more endocrine therapies in the metastatic setting. The ADC (n = 436) led to a 36% reduction in the risk of disease progression or death vs chemotherapy (n = 430; HR, 0.64; 95% CI, 0.54-0.76; P < .0001), according to findings from the phase 3 DESTINY-Breast06 trial (NCT04494425). The confirmed ORRs in the respective arms were 62.6% and 34.4%.

In another exclusive interview with OncLive, Bardia discussed the significance of the approval.

Other Noteworthy Decisions

The FDA cleared treosulfan (Grafapex) plus fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation in adult and pediatric patients aged 1 year and older with acute myeloid leukemia or myelodysplastic syndrome.

Approved Assays

• The FoundationOne CDx test has been greenlit for use as a companion diagnostic to assess BRAF alteration status in pediatric patients aged 6 months or older with relapsed or refractory low-grade glioma who might be eligible to receive tovorafenib (Ojemda), which received accelerated approval in April 2024.
• The therascreen KRAS RGQ PCR Kit (QIAGEN GmbH) for use as a companion diagnostic device to assist in the identification of patients with CRC who tumors harbor KRAS G12C mutations and could be eligible to receive sotorasib paired with panitumumab.