Onco-Summaries: Daily Oncology Updates at a Glance

27/01/2026

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• Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma

• Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL

• Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma

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Johnson & Johnson's DARZALEX FASPRO regimen has been approved in the US for multiple myeloma (Ref)

The US FDA granted approval to Johnson & Johnson's DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).

• The approval is based on the pivotal Phase 3 CEPHEUS/NCT03652064 trial

• Saad Z. Usmani, M.D., Chief, Myeloma Service, Memorial Sloan Kettering Cancer Center and CEPHEUS principal investigator: “D-VRd increased the depth and durability of responses, significantly reduced the risk of disease progression or death, and nearly doubled the rate of sustained minimal residual disease (MRD)-negativity compared to VRd in patients ineligible for ASCT, solidifying this regimen as a potential standard of care for newly diagnosed patients with multiple myeloma. MRD-negativity is a potential predictor of prolonged progression-free and overall survival and D-VRd is now the only quadruplet regimen approved by the FDA based on a study with MRD-negativity as a primary endpoint.”

Imviva Biotech's CTD402 CAR-T received the FDA orphan drug designation for T-ALL/LBL (Ref)

The US FDA granted the orphan drug designation to Imviva Biotech's CTD402 (anti-CD7 CAR-T cell therapy) for the treatment of relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL).

• CTD402 is currently being evaluated in the global Phase 1b/2 TENACITY-01/NCT07070219 trial

• Jan Davidson-Moncada, CMO, Imviva Biotech: "Receiving orphan drug designation for CTD402 is an important milestone for patients with relapsed or refractory T‑ALL/LBL, who urgently need more effective and accessible treatment options. This recognition provides regulatory support and extended market exclusivity to advance our development pathway, supporting our belief that a truly off‑the‑shelf CAR‑T therapy, available at the point of care, has the potential to change the treatment paradigm for these rapidly progressing diseases.”

Nanjing Leads Biolabs' LBL-034 received the FDA fast track designation for multiple myeloma (Ref)

The US FDA granted the fast track designation to Nanjing Leads Biolabs' LBL-034 (GPRC5D x CD3 BsAb) for the treatment of relapsed/refractory multiple myeloma.

• LBL-034 has demonstrated promising efficacy signals in both preclinical and clinical studies and is currently undergoing Phase 1/2 trials to evaluate its potential for treating malignant plasma cell neoplasms