Withdrawn Oncology /Hematologic Malignancies Accelerated Approvals

Trodelvy (sacituzumab govitecan-hziy) Treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor  04/13/2021 11/22/2024 Exkivity (mobocertinib) Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy 9/15/2021 7/15/2024 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 9/14/2017 3/18/2024 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 2/26/2021 2/23/2024 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

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