타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 2개 · 임상 갱신 필요 2개 · Data Tier에서 열림
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | ||
|---|---|---|
Overview Program | Darzalex (daratumumab) | Tecvayli (teclistamab-cqyv) |
Overview Company | Janssen | Johnson & Johnson |
Overview Modality | ANTIBODY | ANTIBODY |
Overview Target | CD38 | BCMA × CD3 |
Overview Indication | Multiple myeloma | Relapsed or refractory multiple myeloma |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved |
Positioning Key differentiator | Direct on-tumor + immunomodulatory effects | No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma. |
Positioning Known limitation | CD38 downregulation, high tumor burden, and impaired effector function after prior lines. | BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion. |
Positioning Development positioning | — | 5L+ (label), earlier in practice and ongoing trials |
MoA Mechanism | Daratumumab binds CD38 on plasma cells and other immune cells, inducing direct apoptosis, Fc-mediated ADCC/CDC, and immunomodulatory effects including depletion of CD38+ regulatory cells and enhanced T-cell clonality. | Simultaneously engages BCMA on plasma cells and CD3 on T cells, forming an immune synapse that redirects polyclonal T cells to lyse BCMA+ myeloma cells independent of TCR specificity. |
MoA Biomarker | CD38 expression on clonal plasma cells (universal in MM). | BCMA expression, MRD negativity, serum free light chain response. |
Toxicology Species | Cynomolgus monkey | — |
Toxicology Animal (cat.) | NHP | — |
Toxicology Major finding | Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate. | Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity. |
Toxicology CRS | N/A | CRS ~72%, grade ≥3 ~0.6% |
Clinical Safety signal | Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate. | Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity. |
Clinical Program phase | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
타깃 · 모달리티 · 임상 근거 · 비임상 맥락으로 최대 5개 프로그램을 나란히 비교합니다. · 자동 수집 갱신 권장 · 9월 2일
현재 선택: 2개 · 임상 갱신 필요 2개 · Data Tier에서 열림
프로그램 상세에서 관심 등록 후 2개 이상 모으면 여기서 한 번에 비교할 수 있습니다.
표가 넓으면 좌우로 스크롤하세요. 핵심 비교 모드에서는 중요 항목만 표시됩니다.
| 항목 | ||
|---|---|---|
Overview Program | Darzalex (daratumumab) | Tecvayli (teclistamab-cqyv) |
Overview Company | Janssen | Johnson & Johnson |
Overview Modality | ANTIBODY | ANTIBODY |
Overview Target | CD38 | BCMA × CD3 |
Overview Indication | Multiple myeloma | Relapsed or refractory multiple myeloma |
Overview Phase | APPROVED | APPROVED |
Overview Status | APPROVED | APPROVED |
Overview Content status | Curated Core | Curated Core |
Overview Data Confidence | Editorial scope · Curated Core | Editorial scope · Curated Core |
Overview Development Signal | Development Signal · Established | Development Signal · Established |
Overview Approval status | FDA approved | FDA approved |
Positioning Key differentiator | Direct on-tumor + immunomodulatory effects | No manufacturing slot needed, so it can be started immediately in rapidly progressing myeloma. |
Positioning Known limitation | CD38 downregulation, high tumor burden, and impaired effector function after prior lines. | BCMA loss, soluble BCMA acting as a sink, and T-cell exhaustion. |
Positioning Development positioning | — | 5L+ (label), earlier in practice and ongoing trials |
MoA Mechanism | Daratumumab binds CD38 on plasma cells and other immune cells, inducing direct apoptosis, Fc-mediated ADCC/CDC, and immunomodulatory effects including depletion of CD38+ regulatory cells and enhanced T-cell clonality. | Simultaneously engages BCMA on plasma cells and CD3 on T cells, forming an immune synapse that redirects polyclonal T cells to lyse BCMA+ myeloma cells independent of TCR specificity. |
MoA Biomarker | CD38 expression on clonal plasma cells (universal in MM). | BCMA expression, MRD negativity, serum free light chain response. |
Toxicology Species | Cynomolgus monkey | — |
Toxicology Animal (cat.) | NHP | — |
Toxicology Major finding | Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate. | Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity. |
Toxicology CRS | N/A | CRS ~72%, grade ≥3 ~0.6% |
Clinical Safety signal | Infusion-related reactions (premedication required), cytopenias, and increased infection risk; subcutaneous formulation reduces IRR rate. | Boxed warning for CRS and neurologic toxicity including ICANS. Profound hypogammaglobulinemia and infection — including opportunistic infection — drive most late morbidity. |
Clinical Program phase | APPROVED | APPROVED |
Clinical Trial activity | No active/completed counts | No active/completed counts |
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