Table 3.
Promising Late-Phase Drugs for Hematologic Malignancies
| Drug trade name (generic) | Manufacturer | Expected indication/therapeutic class/route | Development stage/comments (expected approval) |
|---|---|---|---|
| Daratumumab | Janssen Biotech | For relapsed/refractory multiple myeloma; anti-CD38 monoclonal antibody (immunotherapy); IV | BT: 5/1/13 Phase 3 trials |
| Ixazomib (MLN9708) | Takeda Oncology | For relapsed/refractory multiple myeloma (systemic light-chain amyloidosis); proteasome inhibitor; oral | BT: 1/12/14 Phase 3 trials |
| Elotuzumab | Bristol-Myers Squibb | In combination with lenalidomide and dexamethasone for patients with multiple myeloma who have received ≥1 previous therapies; humanized immunoglobulin G1 monoclonal antibody; IV | BT: 5/19/14 Phase 3 trials |
| Volasertib | Boehringer Ingelheim | For patients aged ≥65 years with previously untreated AML who are ineligible for intensive remission induction therapy; PLK inhibitor; IV | BT: 9/17/13 Phase 2 trials Orphan drug: 5/13/14 |
| CTL019 | Novartis | For relapsed/refractory ALL in pediatric or adult patients; CAR T-cell therapy; IV | BT: 7/7/14 Phase 1/2 trials |
| JCAR015 | Juno Therapeutics | For relapsed/refractory B-cell ALL; CAR T-cell therapy; IV | BT: 11/24/14 Phase 1/2 trials Orphan drug: 11/18/14 |
| Venetoclax (ABT-199/RG7601) | AbbVie/Roche | Oral, selective B-cell lymphoma 2 inhibitor, in combination with chemotherapy, for relapsed/refractory CLL | BT: 5/6/15 Phase 3 trials |
| Pracinostat | MEI Pharma | Oral HDAC inhibitor for myelodysplastic syndrome | Phase 2/3 trials |
| Vosaroxin | Sunesis Pharmaceuticals | First-in-class quinolone derivative for relapsed/refractory AML; IV | Phase 3 trials |
| Quizartinib | Ambit Biosciences | Treatment of newly diagnosed patients and patients with relapsed or refractory FLT3-ITD–positive and FLT3-ITD–negative AML; tyrosine kinase inhibitor; oral | Phase 3 trials |
ALL indicates acute lymphoblastic leukemia; AML, acute myeloid leukemia; BT, breakthrough therapy; CAR, chimeric antibody receptor; CLL, chronic lymphocytic leukemia; HDAC, histone deacetylase; IV, intravenous; PLK, polo-like kinase.