Breaking Down Cancer Therapies Approved by the FDA in January 2025

Over the course of January, the Food and Drug Administration (FDA) granted approval to several therapeutic agents in the field of oncology across indications including HER2-low and HER2-ultralow breast cancer, acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), as well as others.

Here is a select list of cancer therapies approved by the regulatory agency over the last month.

Calquence (acalabrutinib) Therapy Combination for Mantle Cell Lymphoma

On Jan. 16, the FDA granted traditional approval to treatment with Calquence plus bendamustine and Rituxan (rituximab) for adults with previously untreated MCL who are not eligible for autologous hematopoietic stem cell transplantation (HSCT).

In the ECHO trial, the efficacy of the Calquence combination was evaluated in 598 patients with MCL who were at least 65 years old. These patients were ineligible for HSCT, and they were treated with Calquence plus bendamustine and Rituxan or placebo plus bendamustine and Rituxan. Notably, the median progression-free survival was 66.4 months in the Calquence arm and 49.6 in the placebo arm at a median follow-up of 49.8 months.

Lumakras (sotorasib) with Vectibix (panitumumab) in KRAS G12C+ Colorectal Cancer

On Jan. 16, Lumakras with Vectibix was approved by the FDA for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC). In order to be enrolled, patients must have received previous fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy.

The CodeBreaK 300 trial evaluated the efficacy of the now-approved treatment combination in 160 patients with KRAS G12C-mutated mCRC who had previously been treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy. Treated with Lumakras with Vectibix therapy demonstrated a median PFS of 5.6 months for patients who were treated with 960 mg of Lumakras /Vectibix arm and 2 months in the standard of care arm. Furthermore, for patients on the Lumakras/Vectibix arm, the objective response rate (ORR) was 26% compared with 0 on the standard of care arm.

Datroway Treatment for HR+, HER2- Breast Cancer

On Jan. 17, the FDA granted approval to treatment with Datroway (datopotamab deruxtecan-dlnk) for adults with unresectable or metastatic, hormone receptor (HR)-positive, HER2-negative breast cancer following prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The TROPION-Breast01 trial evaluated the efficacy of the Trop-2-directed antibody and topoisomerase inhibitor conjugate in 732 patients compared with an investigator’s choice of chemotherapy. Patients being treated on the Datroway arm had a median PFS of 6.9 months versus the 4.9-month median PFS patients on the chemotherapy arm experienced. Additionally, the respective median overall survival rates were 18.6 months and 18.3 months; the ORR was 36% and 23%; and the median duration of response was 6.7 months and 5.7 months.

Grafapex (treosulfan)/Fludarabine Before alloHSCT in AML and MDS

On Jan. 24, the FDA granted approval to the alkylating agent, Grafapex, plus fludarabine in the preparative treatment of adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) receiving allogeneic hematopoietic stem cell transplantation (alloHSCT).

The phase 2 MC-FludT.14/L trial compared treatment of Grafapex in 280 patients with busulfan in 290 patients prior to alloHSCT. In the randomized patient population, the hazard ratio for overall survival (OS; stratified by donor type and risk group) for the now-FDA-approved regimen compared with busulfan, was 0.67; in patients with AML or MDS, these numbers were 0.73 and 0.64, respectively.

Enhertu (fam-trastuzumab deruxtecan-nxki) Therapy in HER2-Low and -Ultralow Breast Cancer

It was announced on Jan. 27 that the antibody drug conjugate Enhertu was granted FDA approval for the treatment of patients with unresectable or metastatic HR-positive, HER2-low or -ultralow breast cancer following disease progression on one or more endocrine therapies in the metastatic setting.

In the DESTINY-Breast06 trial, Enhertu demonstrated a 36% reduction in the risk for disease progression or death compared with chemotherapy in the 866 patients with chemotherapy-naïve, HR-positive, HER2-low or -ultralow metastatic breast cancer that were evaluated. The median PFS was 13.2 months in the investigative group compared with 8.1 months in the chemotherapy group.

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