The FDA granted approvals and clearances for multiple oncology therapies in December 2025, affecting treatment options across hematologic malignancies, solid tumors, transplant-related complications, and prostate cancer diagnostics.
Dec. 3 — Pirtobrutinib (Jaypirca) received traditional approval for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after prior covalent BTK inhibitor therapy. The phase 3 BRUIN CLL-321 trial showed a median progression-free survival (PFS) of 11.2 months with pirtobrutinib versus 8.7 months with investigator’s choice (HR, 0.58; 95% CI, 0.38–0.89; P = .0105). Overall survival analyses were confounded by high crossover. The approval converts prior accelerated status to full approval, establishing a noncovalent BTK inhibitor option with favorable tolerability for a heavily pretreated population.
Dec. 4 — Lisocabtagene maraleucel (liso-cel; Breyanzi) was approved for adults with relapsed or refractory marginal zone lymphoma (MZL) after at least two prior lines of systemic therapy. In the MZL cohort of the phase 2 TRANSCEND FL trial, liso-cel produced an overall response rate (ORR) of 84.4% (95% CI, 74.4%–91.7%) and a complete response (CR) rate of 55.8% (95% CI, 44.1%–67.2%); median duration of response was not reached. This expands CAR T-cell therapy into MZL, offering deep and durable remissions for patients with limited options.
Dec. 9 — Omidubicel-onlv (Omisirge) was approved for adult and pediatric patients aged 6 years and older with severe aplastic anemia (SAA) undergoing reduced-intensity conditioning who lack a compatible donor. An ongoing phase 1/2 study showed early and sustained neutrophil engraftment with a median time to recovery of 11 days (range, 7–20); interim ASH data reported rapid neutrophil recovery in 95% of heavily pretreated patients (median, 8 days) and favorable disease-free survival and low graft-versus-host disease rates. This is the first FDA-approved hematopoietic stem cell transplant therapy for this population and may shorten time to hematopoietic recovery.
Dec. 12 — Niraparib in combination with abiraterone acetate (Akeega) plus prednisone was approved for adult patients with deleterious or suspected deleterious BRCA2-mutated metastatic castration-sensitive prostate cancer (mCSPC), as identified by an FDA-approved test. An exploratory BRCA2 subgroup analysis from the phase 3 AMPLITUDE trial showed significantly improved radiographic PFS (rPFS not estimable vs 26 months; HR, 0.46; 95% CI, 0.32–0.66) and delayed time to symptomatic progression (HR, 0.41; 95% CI, 0.26–0.65). The benefit was restricted to BRCA2-mutated disease, supporting early molecular testing and precision treatment intensification in mCSPC.
Dec. 15 — Fam-trastuzumab deruxtecan-nxki (T-DXd; Enhertu) plus pertuzumab (Perjeta) was approved as frontline treatment for adults with unresectable or metastatic HER2-positive breast cancer. The phase 3 DESTINY-Breast09 trial reported a median PFS of 40.7 months with T-DXd plus pertuzumab versus 26.9 months with trastuzumab, pertuzumab and a taxane (THP) (HR, 0.56; 95% CI, 0.44–0.71; P < .0001). Confirmed ORR was 87% versus 81%. The regimen establishes an antibody–drug conjugate–based option as a new first-line standard for advanced HER2-positive disease.
Dec. 17 — Rucaparib (Rubraca) received regular approval for adults with BRCA mutation–associated metastatic castration-resistant prostate cancer (mCRPC) after prior androgen receptor–directed therapy. The phase 3 TRITON3 trial showed median rPFS of 11.2 months with rucaparib versus 6.4 months with physician’s choice (HR, 0.50; 95% CI, 0.36–0.69; P < .0001). These data confirm rucaparib as an effective targeted option earlier in mCRPC and reinforce the need for molecular testing to identify BRCA-driven disease.
Dec. 18 — A subcutaneous formulation of amivantamab with hyaluronidase-lpuj (Rybrevant Faspro) was cleared for patients with EGFR-mutated non–small cell lung cancer (NSCLC) across the intravenous amivantamab indications. The phase 3 PALOMA-3 study demonstrated noninferior pharmacokinetics and comparable clinical activity when combined with lazertinib, with ORRs of 30% (subcutaneous) versus 33% (intravenous) and median PFS of 6.1 versus 4.3 months. The subcutaneous option reduces administration time and infusion-related reactions and is expected to improve convenience and clinic workflow.
Dec. 22 — Subcutaneous mosunetuzumab (Lunsumio VELO) was cleared for adults with relapsed or refractory follicular lymphoma after two or more prior systemic therapies. In the phase 1/2 GO29781 study, fixed-duration subcutaneous mosunetuzumab achieved an ORR of 75% (95% CI, 64%–83%) and a CR rate of 59% (95% CI, 48%–69%), with a median duration of response of 22.4 months and median PFS of 23.7 months. Efficacy was comparable to intravenous dosing; cytokine release syndrome occurred in 29.8% of patients and resolved in all cases. The subcutaneous formulation supports outpatient delivery with reduced treatment burden.
Dec. 30 — Narsoplimab-wuug (Yartemlea) was approved for adults and pediatric patients aged 2 years and older with hematopoietic stem cell transplant–associated thrombotic microangiopathy (TA-TMA). A single-arm study and expanded access program showed a TMA complete response rate of 61% and improvements in platelet counts, lactate dehydrogenase, organ function and transfusion independence, with an approximate 73% 100-day survival rate from TMA diagnosis. This is the first approved therapy for TA-TMA and represents a major advance in post-transplant care.
The FDA also approved the IsoPSA in vitro diagnostic kit through premarket approval as an aid in diagnosing high-grade prostate cancer in men aged 50 years and older with elevated prostate-specific antigen levels.
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