This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications1 that have been subsequently withdrawn, and are therefore, no longer FDA-approved.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Withdrawn indications are not listed until FDA publishes a Federal Register notice to that effect or updates product labeling.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 Date2|
|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 CD38-directed monoclonal antibody||2/26/2021||10/22/2021|
|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|
- 1. Each unique oncology indication-product pairing is listed individually (this database excludes supportive care products and changes to dosing or formulation).
- 2. Withdrawal date indicates either the effective date published by the Federal Register or the date the product label was updated, whichever date came first.