Withdrawn | Cancer Accelerated Approvals
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. Visit the ongoing or verified AA indication pages for more information.
Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling.
| Drug Name | Accelerated Approval (AA) Indication | Accelerated Approval Date | Withdrawal Date 1 |
|---|---|---|---|
| Truseltiq (infigratinib) | Treatment of adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangement as detected by an FDA approved test | 5/28/2021 | 5/16/2024 |
| Aliqopa (copanlisib) | Treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies | 09/14/2017 | 03/18/2024 |
| Pepaxto (melphalan flufenamide) | In combination with dexamethasone for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal antibody | 02/26/2021 | 02/23/2024 |
| Gavreto (pralsetinib) | Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy | 12/1/2020 | 7/20/2023 |
| Imbruvica (ibrutinib) | Adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy | 11/13/2013 | 5/18/2023 |
| Imbruvica (ibrutinib) | Adult patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy | 1/18/2017 | 5/18/2023 |
| Blenrep (belantamab mafodotin-blmf) | Adults patients with relapsed or refractory (R/R) multiple myeloma (MM) who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent | 8/5/2020 | 2/6/2023 |
| Tecentriq (atezolizumab) | Patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 as determined by an FDA approved test or who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status | 4/17/2017 | 12/2/2022 |
| Ukoniq (umbralisib) | Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20- based regimen | 2/5/2021 | 5/31/2022 |
|
Ukoniq (umbralisib) |
Adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy | 2/5/2021 | 5/31/2022 |
| Marqibo (vincristine sulfate liposomal) | Adults with Philadelphia (PH) chromosome negative (-) ALL in second relapse or greater relapsed or whose disease has progressed following 2 or greater treatment lines of anti-leukemia therapies | 8/9/2012 | 5/2/2022 |
| Farydak (panobinostat) | In combination with bortezomib (BTZ) and dexamethasone (DEX) for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior regimens, including BTZ and an immunomodulatory agent. | 2/23/2015 | 3/24/2022 |
| Zydelig (idelalisib) | For the treatment of relapsed follicular B-cell Non-Hodgkin Lymphoma (FL) in patients who have received at least 2 prior systemic therapies and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapies | 7/23/2014 | 2/18/2022 |
| Keytruda (pembrolizumab) | For patients with recurrent or locally advanced or metastatic gastric or GEJ adenocarcinoma whose tumors express PD-L1 [CPS ≥1] as determined by an FDA-approved test, with disease progression on/after two or more prior lines of therapy including fluoropyrimidine and platinum containing chemotherapy and if appropriate, HER2/NEU targeted therapy | 9/22/2017 | 2/4/2022 |
| Copiktra (duvelisib) | Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies | 9/24/2018 | 12/17/2021 |
| Keytruda (pembrolizumab) | Metastatic SCLC with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy | 6/17/2019 | 3/30/2021 |
| Tecentriq (atezolizumab) | In combination with paclitaxel protein-bound for unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering = 1% of the tumor area), as determined by an FDA-approved test. | 3/8/2019 | 10/6/2021 |
| Opdivo (nivolumab) | Metastatic SCLC with progression after platinum-based chemotherapy and at least one other line of therapy | 8/16/2018 | 12/29/2020 |
| Opdivo (nivolumab) | Hepatocellular carcinoma previously treated with sorafenib | 9/22/2017 | 7/23/2021 |
| Imfinzi (durvalumab) | Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy | 5/1/2017 | 2/19/2021 |
| Lartruvo (olaratumab) | In combination with doxorubicin for adults with soft tissue sarcoma with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery | 10/19/2016 | 2/25/2020 |
| Tecentriq (atezolizumab) | Locally advanced or metastatic urothelial carcinoma that progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy | 5/18/2016 | 4/13/2021 |
| Istodax (romidepsin) | Peripheral T-cell lymphoma in patients who have received at least one prior therapy | 6/16/2011 | 7/30/2021 |
| Oforta (fludarabine phosphate) | For adults with B-cell CLL that has not responded to or progressed during or after treatment with at least one standard alkylating agent containing regimen | 12/18/2008 | 12/31/2011 |
| Avastin (bevacizumab) | In combination with paclitaxel for patients who have not received chemotherapy for metastatic HER2 negative breast cancer | 2/22/2008 | 11/18/2011 |
| Bexxar (tositumomab and iodine i 131 tositumomab) | For patients with relapsed or refractory low-grade follicular or transformed CD20+ NHL who have not received rituximab | 12/22/2004 | 10/23/2013 |
| Iressa (gefitinib) | As monotherapy for locally advanced or metastatic NSCLC after failure of platinum-based and docetaxel chemotherapy | 5/5/2003 | 4/25/2012 |
| Mylotarg (gemtuzumab ozogamicin) | For patients with CD33+ AML in first relapse 60 years of age or older and not candidates for cytotoxic chemotherapy | 5/17/2000 | 11/28/2011 |
| Celebrex (celecoxib) | To reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis patients, as an adjunct to usual care | 12/23/1999 | 6/8/2012 |
- 1Withdrawal date indicates either the effective date published by the Federal Register or the date the product label was updated, whichever date came first.