First CAR-T Approved for CLL
In March, the FDA granted accelerated approval to lisocabtagene maraleucel (liso-cel, Breyanzi) for pretreated CLL or small lymphocytic lymphoma (SLL). This CD19-directed cellular therapy is the first CAR-T product specifically for CLL/SLL, offering a one-time infusion for patients with relapsed or refractory disease following two or more prior therapies.
Moving the Needle in Richter Transformation
New studies have evaluated treatment options for Richter transformation, a rare complication of CLL/SLL. The BRUIN study highlighted the efficacy of pirtobrutinib (Jaypirca), with half of the patients responding to the treatment. The MOLTO study also showed promising results with a three-drug regimen for treating the diffuse large B-cell lymphoma variant of Richter transformation.
New Data on Triplets for CLL
Updated results from a prospective study revealed that a fixed-duration, three-drug regimen for CLL achieved deep and durable remissions lasting for up to 7 years. The regimen involving ibrutinib, venetoclax, and obinutuzumab showed significant progression-free survival (PFS) and overall response rates.
Ibrutinib's Negotiated Medicare Price
In August, the Centers for Medicare & Medicaid Services (CMS) announced a 38% decrease in the price of ibrutinib, from $14,934 to $9,319, effective January 2026. This change is part of Medicare's drug-price negotiation program under the Inflation Reduction Act.
New Labeling for Fludarabine
In November, the FDA updated the drug labeling for fludarabine, reflecting its use in combination with cyclophosphamide and rituximab for adults with B-cell CLL, and as monotherapy for those who have failed on a prior regimen containing an alkylating agent.
Fixed-Duration Oral Doublet for Fit CLL Wins in Frontline Setting
At the American Society of Hematology (ASH) annual meeting, findings from a phase III study showed that a fixed-duration oral combination of acalabrutinib plus venetoclax significantly improved PFS compared with chemoimmunotherapy in fit patients with previously untreated CLL.
These developments underscore the ongoing progress in CLL treatment, offering new hope and options for patients.
