A9.
Major new drugs and indications for treatment of lymphoma approved to market by US FDA but not in China
| Drug name | Mechanism of action | FDA approved indications | Approved time to market |
| FDA, Food and Drug Administration; MMAE, monomethyl auristatin E; CLL, chronic lymphocytic leukemia; cHL, classical Hodgkin’s lymphoma; ALCL, anaplastic large cell lymphoma; pcALCL, primary cutaneous anaplastic large cell lymphoma; MF, m11ycosis fungoides; MCL, mantle cell lymphoma; FL, follicular lymphoma; PTCL, peripheral T cell lymphoma. | |||
| Alemtuzumab | Humanized CD52 monoclonal antibody | Alkylating agent and fludarabine resistant advanced CLL | May 2001 |
| Belinostat | Histone deacetylase inhibitor | Relapse, refractory peripheral T-cell lymphoma | July 2014 |
| Bendamustine | Bifunctional alkylating agent | 1. CLL2. Indolent B-cell lymphoma | March 2008 |
| Brentuximab
vedotin |
CD30 mAb coupled to cytotoxin MMAE | 1. Autologous hematopoietic stem cell transplantation failed or not suitable for autologous hematopoietic stem cell transplantation, at least second-line treatment failed cHL | October 2011 |
| 2. Consolidation treatment for patients with high risk of relapse or progression after autologous hematopoietic stem cell transplantation | |||
| 3. ALCL that fails after first-line multi-drug combined chemotherapy | |||
| 4. Relapse refractory pcALCL and MF expressing CD30 | November 2017 | ||
| 5. Combined with chemotherapy for previously treated stage III or IV cHL | March 2018 | ||
| Idelalisib | Selective PI3Kδ (phosphatidylinositol 3-kinase) inhibitor | 1. Combined with rituximab for relapsed CLL | July 2014 |
| 2. FL and CLL with at least second-line treatment failure | |||
| Ibrutinib | BTK inhibitor | 1. MCL with at least first-line treatment failure | November 2013 |
| 2. CLL failed in first-line chemotherapy | |||
| 3. CLL with del (17p) gene mutations | |||
| 4. Waldenstrom macroglobulinemia | |||
| Lenalidomide | Immunomodulator | MCL failed in second-line chemotherapy | May 2013 |
| Obinutuzumab | Humanized and glycosylated CD20 mAb | Combined with chlorambucil for initial treatment of CLL | November 2013 |
| Ofatumumab | Fully humanized CD20 mAb | Refractory CLL with ineffective treatment of fludarabine | April 2014 |
| Pralatrexate | Folate metabolism inhibitor | Recurrent or refractory PTCL | September 2009 |
| Romidepsin | Histone deacetylase inhibitors | Cutaneous T-cell lymphoma failed in first-line treatment | November 2009 |
| Vorinostat | Histone deacetylase inhibitors | Cutaneous T-cell lymphoma failed in second-line treatment | October 2006 |
| Copanlisib | Selective PI3Kδ (phosphatidylinositol 3-kinase) inhibitor | FL with at least second-line treatment failure | September 15, 2017 |
| Acalabrutinib | BTK inhibitor | CLL with at least first-line treatment failure | November 1, 2017 |
| Yescarta | anti-CD19 CAR-T | Relapsed/refractory large B cell lymphoma | October 18, 2017 |
| Nivolumab | PD-1 mAb | cHL that progressed after HDC/AHSCT or could not receive transplantation and progressed after previous three chemotherapies | May 17, 2016 |
| Pembrolizumab | PD-1 mAb | Refractory cHL and cHL relapse after previous treatment with 3 or more regimens | March 14, 2017 |
| Obinutuzumab | Humanized and glycosylated CD20 mAb | Combined with chemotherapy for previously untreated advanced FL | November 21, 2017 |