Table 1.
FDA haematology (cancer) approvals for 2011–2015
| Drug | Year | Indicated blood cancera | Previous approvals |
|---|---|---|---|
| Belinostat (BELEODAQ, Spectrum Pharmaceuticals, Inc.) | 2014 | Relapsed or refractory peripheral T-cell lymphoma (PTCL) | |
| Blinatumomab (BLINCYTO, Amgen Inc.) | 2014 | Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (R/R ALL) | |
| Bosutinib tablets (Bosulif, Pfizer, Inc.) | 2012 | Philadelphia chromosome positive (Ph+) chronic myelogenous leukaemia (CML) | |
| Brentuximab vedotin (Adcetris for injection, Seattle Genetics, Inc.) | 2011 | (1) Hodgkin lymphoma (2) systemic anaplastic large cell lymphoma (ALCL) |
|
| Carfilzomib injection (Kyprolis, Onyx Pharmaceuticals), | 2012 | Multiple myeloma | |
| Erwinia chrysanthemi [Erwinaze, injection, EUSA Pharma (USA), Inc.] | 2011 | Acute lymphoblastic leukaemia (ALL) | |
| Ibrutinib (Imbruvica capsules, Pharmacyclics, Inc.) | 2015 | Waldenstrom’s macroglobulinemia (WM). | Previous approval (2014) for chronic lymphocytic leukaemia (CLL) |
| Ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) | 2014 | Chronic lymphocytic leukaemia (CLL) | Previous approval (2014) for mantle cell lymphoma |
| Ibrutinib (IMBRUVICA, Pharmacyclics, Inc.) | 2013 | Mantle cell lymphoma (MCL) | |
| Idelalisib (Zydelig tablets, GileadSciences, Inc.) | 2014 | Relapsed chronic lymphocytic leukaemia (CLL) | |
| Lenalidomide capsules (REVLIMID, Celgene Corporation) | 2013 | Mantle cell lymphoma (MCL) | |
| Obinutuzumab (GAZYVA injection, for intravenous use, Genentech, Inc.; previously known as GA101) | 2013 | Chronic lymphocytic leukaemia (CLL) | |
| Ofatumumab (Arzerra Injection, for intravenous infusion; GlaxoSmithKline) | 2014 | Chronic lymphocytic leukaemia (CLL), | |
| Omacetaxine mepesuccinate (SYNRIBO for Injection, for subcutaneous use, Teva Pharmaceutical Industries Ltd.), | 2012 | Chronic myeloid leukaemia (CML) | |
| Oral suspension of mercaptopurine (Purixan, NOVA Laboratories Limited) | 2014 | Acute lymphoblastic leukaemia (ALL) | |
| Panobinostat (FARYDAK capsules, Novartis Pharmaceuticals) | 2015 | Multiple myeloma | |
| Pomalidomide (POMALYST capsules, Celgene Corporation) | 2013 | Multiple myeloma | |
| Ponatinib (Iclusig tablets, ARIAD Pharmaceuticals, Inc.) | 2012 | Chronic myeloid leukaemia (CML) or Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) | |
| Rituximab (Rituxan, Genentech, Inc) | 2011 | Follicular, CD-20 positive, B-cell non-Hodgkin lymphoma | |
| Ruxolitinib (Jakafi, Incyte Corporation) | 2014 | Polycythemia vera (PV) | Previous approval (2011) for myelofibrosis |
| Ruxolitinib (Jakafi oral tablets, Incyte Corporation) | 2011 | Myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis | |
| Vincristine sulfate liposome injection (Marqibo, Talon Therapeutics, Inc.) | 2012 | Philadelphia chromosome-negative (Ph−) acute lymphoblastic leukaemia (ALL) |
Until end of May 2015
aFor further details on the Haematology/Oncology (Cancer) Approvals & Safety Notifications see:http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm