Bortezomib

Johnson & Johnson on Monday shared detailed survival data from a Phase III study evaluating a combination of its anti-BCMA bispecific Tecvayli (teclistamab-cqyv) plus Darzalex Faspro (daratumumab/hyaluronidase-fihj) in patients with relapsed/refractory multiple myeloma (MM) who had received one to three prior lines of treatment. Yusri Elsayed, J&J's global therapeutic area head for oncology, had said the duo was "poised to be a new standard of care option" when top-line results from the 587-patient MajesTEC-3 trial were shared last month (see – ViewPoints: J&J continues to raise its own bar in MM).Physicians also see Tecvayli as the preferred bispecific for MM. The results of a recent FirstWord poll showed that it was the top choice for 47% of US haematologists and oncologists, ranking it above other bispecifics including Talvey (talquetamab), Elrexfio (elranatamab) and Lynozyfic (linvoseltamab). For more on which treatments doctors are picking for their MM patients, see Physician Views In-Depth: US oncologists heavily favour Tecvayli among MM bispecifics.'Clinically remarkable'The pharma had reported in October that the Tecvayli-Darzalex Faspro combo helped patients with MM live significantly longer without their disease worsening than those on two standard-of-care comparators — investigator's choice of either Darzalex Faspro plus pomalidomide and dexamethasone, or Darzalex Faspro plus bortezomib and dexamethasone (DPd/DVd).Now, J&J has pulled back the curtain on the study's survival specifics in a late-breaking abstract posted ahead of the American Society of Hematology (ASH) meeting (see – Spotlight On: Late-breakers to watch at ASH 2025).The drugmaker revealed that its Tecvayli-Darzalex Faspro combo achieved a 36-month progression-free survival (PFS) rate of 83.4%, versus 29.7% for the DPd/DVd comparator arm. While the standard-of-care group saw a median PFS of 18.1 months, that milestone was not reached after a median follow-up of 34.5 months for those taking the experimental regimen. Overall survival "significantly favoured" the doublet, with a hazard ratio of 0.46 and 45 patient deaths, compared to 96 deaths the standard-of-care arm. More than 90% of patients taking Tecvayli-plus-Darzalex Faspro who were alive after 6 months remained alive at the 30-month mark, and close to half remained on treatment as of the data cut-off. J&J's duo also bested DPd/DVd on several key secondary measures, including complete response rate (81.8% versus 32.1%), overall response rate (89% vs 75.3%) and MRD-negativity rate (58.4% vs 17.1%), all of which were statistically significant results. The rate of treatment-emergent adverse events (TEAEs) was comparable between the two study arms. Serious TEAEs occurred in 70.7% of those taking Tecvayli-Darzalex Faspro with a discontinuation rate of 4.6%, versus 62.4% and 5.5%, respectively, for the comparator group. Grade 1 and 2 cytokine release syndrome (CRS) was reported in 44.2% and 15.9% of doublet recipients, respectively; the rate of immune effector cell-associated neurotoxicity syndrome (ICANS) was 1.1%.The abstract authors described the findings as "clinically remarkable," adding that the off-the-shelf immunotherapy combination could represent a new standard-of-care for relapsed/remitting MM as early as first relapse.

On November 19, 2025, the Food and Drug Administration granted traditional approval to daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech Inc.) with bortezomib, cyclophosphamide, and dexamethasone (VCd) for newly diagnosed light chain (AL) amyloidosis. FDA granted accelerated approval for this indication in 2021. Full prescribing information for Darzalex Faspro will be posted on Drugs@FDA . Efficacy was evaluated in ANDROMEDA (NCT03201965), an open-label, randomized, active-controlled trial in 388 patients with newly diagnosed AL amyloidosis with measurable disease and at least one affected organ according to consensus criteria. Patients were randomized to receive bortezomib, cyclophosphamide, and dexamethasone (VCd) or Darzalex Faspro with VCd (D-VCd). The approval was based on major organ deterioration progression free survival (MOD-PFS; defined as the duration from the date of randomization to either hematologic progression, major organ deterioration, or death, whichever occurred first), and overall survival (OS). After a median follow-up of 61.4 months, the trial demonstrated an improvement in MOD-PFS in the D-VCd arm as compared to the VCd arm (hazard ratio [HR]=0.47; 95% confidence interval [CI]: 0.33, 0.67; p-value <0.0001). The median MOD-PFS was not reached in the D-VCd arm and was 30.2 months in the VCd arm. The trial also demonstrated an improvement in OS in the D-VCd arm as compared to the VCd arm (HR=0.62; 95% CI: 0.42, 0.90; p-value 0.0121). The median OS had not been reached in either arm. The prescribing information includes a Warnings and Precaution for cardiac toxicity, stating that serious or fatal cardiac adverse reactions occurred in patients with light chain (AL) amyloidosis who received Darzalex Faspro in combination with VCd, along with Warnings and Precautions for hypersensitivity and other administrative reactions, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interference with cross-matching and red blood cell antibody screening. Darzalex Faspro is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials. The recommended dose is 1,800 mg daratumumab and 30,000 units hyaluronidase-fihj administered subcutaneously into the abdomen over approximately 3 to 5 minutes according to the recommended schedule in combination with VCd. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA's MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE's Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov . Follow the Oncology Center of Excellence on X: @FDAOncology . Content current as of: 11/19/2025 Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.