2021 in cancer

FDA · US: 115 records / 58 drugsHealth Canada · CA: 76 records / 36 drugsEMA · EU: 25 records / 21 drugs

• Nov 12, 2021Ropeginterferon Alfa-2b FDA · US original application approved Polycythemia VeraThe treatment of adults with polycythemia vera.openfda
• Nov 12, 2021Ropeginterferon Alfa-2b FDA · US original application approved Essential ThrombocythemiaThe treatment of adults with essential thrombocythemia.openfda
• Sep 20, 2021Tisotumab Vedotin FDA · US original application approved Malignant Cervical NeoplasmTIVDAK ® is indicated for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.…openfda
• Aug 13, 2021Belzutifan FDA · US original application approved Clear Cell Renal Cell Carcinomaas monotherapy, for treatment of adult patients with advanced ccRCC following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1)…openfda
• Aug 13, 2021Belzutifan FDA · US original application approved Clear Cell Renal Cell CarcinomaRenal Cell Carcinoma with a Clear Cell Component (ccRCC) in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, for the adjuvant…openfda
• May 28, 2021Sotorasib FDA · US original application approved Lung Non-Small Cell CarcinomaKRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS…openfda
• May 28, 2021Sotorasib FDA · US original application approved Malignant Colorectal NeoplasmKRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combination with panitumumab, for the treatment of adult patients with KRAS G12C-mutated mCRC as…openfda
• May 25, 2021Leuprolide FDA · US original application approved Malignant Prostate NeoplasmCAMCEVI is indicated for the treatment of adult patients with advanced prostate cancer. CAMCEVI is a gonadotropin-releasing hormone (GnRH) agonist indicated…openfda
• May 21, 2021Amivantamab FDA · US original application approved Lung Non-Small Cell CarcinomaFirst-Line Treatment of NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is indicated for the first-line…openfda
• May 21, 2021Amivantamab FDA · US original application approved Lung Non-Small Cell CarcinomaPreviously Treated NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with carboplatin and pemetrexed, is…openfda
• May 21, 2021Amivantamab FDA · US original application approved Lung Non-Small Cell CarcinomaPreviously Treated NSCLC with EGFR Exon 20 Insertion Mutations RYBREVANT is indicated as a single agent for the treatment of adult patients with locally…openfda
• May 21, 2021Amivantamab FDA · US original application approved Lung Non-Small Cell CarcinomaFirst-Line Treatment of NSCLC with EGFR Exon 19 Deletions or Exon 21 L858R Substitution Mutations RYBREVANT, in combination with lazertinib, is indicated for…openfda
• Apr 23, 2021Loncastuximab Tesirine FDA · US original application accelerated approved High Grade B-Cell LymphomaZYNLONTA is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy,…openfda
• Apr 22, 2021Dostarlimab FDA · US original application approved Malignant Endometrial NeoplasmEndometrial Cancer • in combination with carboplatin and paclitaxel, followed by JEMPERLI as a single agent, for the treatment of adult patients with primary…openfda
• Mar 10, 2021Tivozanib FDA · US original application approved Renal Cell CarcinomaFOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic…openfda
• Feb 3, 2021Tepotinib FDA · US original application approved Lung Non-Small Cell CarcinomaTEPMETKO is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition ( MET…openfda
• Nov 22, 2021Sirolimus FDA · US original application approved cancer not stated in this recordFYARRO ® is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor…openfda
• Oct 29, 2021Asciminib FDA · US original application accelerated approved cancer not stated in this recordSCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic…openfda
• Oct 29, 2021Asciminib FDA · US original application accelerated approved cancer not stated in this recordSCEMBLIX is indicated for the treatment of adult patients with: Newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic…openfda
• Oct 4, 2021Sertraline FDA · US original application approved cancer not stated in this recordSertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies ( 14 )] : Major depressive disorder (MDD) in…openfda
• Oct 4, 2021Sertraline FDA · US original application approved cancer not stated in this recordSertraline Hydrochloride (HCl) Capsules is indicated for the treatment of the following [see Clinical Studies ( 14 )] : Major depressive disorder (MDD) in…openfda
• Sep 21, 2021Ruxolitinib FDA · US original application approved cancer not stated in this recordthe topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years…openfda
• Aug 25, 2021Cyclophosphamide FDA · US original application approved cancer not stated in this recordMalignant Diseases Cyclophosphamide Injection is indicated for the treatment of adult and pediatric patients with: malignant lymphomas (Stages III and IV of…openfda
• Aug 13, 2021Belzutifan FDA · US original application approved cancer not stated in this recordvon Hippel-Lindau (VHL) disease for treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma…openfda
• May 28, 2021Sotorasib FDA · US original application accelerated approved cancer not stated in this recordThis indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this…openfda
• Apr 22, 2021Dostarlimab FDA · US original application accelerated approved tumor-agnosticas a single agent for the treatment of adult patients with mismatch repair deficient (dMMR) recurrent or advanced EC, as determined by an FDA-approved test,…openfda
• Dec 9, 2021Amivantamab EMA · EU centralised approved Lung Non-Small Cell CarcinomaRybrevant is indicated: in combination with lazertinib for the first line treatment of adult patients with advanced non small cell lung cancer (NSCLC) with…ema
• Nov 22, 2021Sacituzumab Govitecan EMA · EU centralised approved Triple-Negative Breast CarcinomaTriple-Negative Breast Cancer  Trodelvy is indicated:  as monotherapy for the treatment of adult patients with unresectable locally advanced or…ema
• Aug 26, 2021Tafasitamab EMA · EU centralised approved Diffuse Large B-Cell LymphomaMinjuvi is indicated in combination with lenalidomide followed by Minjuvi monotherapy for the treatment of adult patients with relapsed or refractory diffuse…ema
• Aug 20, 2021Abiraterone Acetate EMA · EU centralised approved Castration-Resistant Prostate CarcinomaAbiraterone Mylan is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer…ema
• Aug 18, 2021Idecabtagene Vicleucel EMA · EU centralised approved Multiple MyelomaAbecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior therapies, including…ema
• Jun 24, 2021Abiraterone Acetate EMA · EU centralised approved Castration-Resistant Prostate CarcinomaAbiraterone Krka is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer…ema
• Jun 17, 2021Azacitidine EMA · EU centralised approved Acute Myeloid LeukemiaOnureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML) who achieved complete remission (CR) or complete remission with…ema
• Apr 26, 2021Abiraterone EMA · EU centralised approved Castration-Resistant Prostate CarcinomaAbiraterone Accord is indicated with prednisone or prednisolone for: the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer…ema
• Apr 21, 2021Dostarlimab EMA · EU centralised approved Malignant Endometrial NeoplasmJemperli is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with primary advanced or recurrent…ema
• Mar 26, 2021Pemigatinib EMA · EU centralised approved CholangiocarcinomaPemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2…ema
• Mar 26, 2021Selinexor EMA · EU centralised approved Multiple MyelomaNEXPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one…ema
• Feb 11, 2021Tucatinib EMA · EU centralised approved Malignant Breast NeoplasmTukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2?positive locally advanced or metastatic…ema
• Jan 7, 2021Tagraxofusp EMA · EU centralised approved Blastic Plasmacytoid Dendritic Cell NeoplasmElzonris is indicated as monotherapy for the first-line treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).ema
• Dec 30, 2021Everolimus FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-30 (see label)openfda
• Dec 20, 2021Enfortumab Vedotin Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as PADCEV (DIN 02521903) under ATC L01FX13 ENFORTUMAB VEDOTIN. Indications are not published in the Drug Product Database — see the Health…health-canada-dpd
• Dec 19, 2021Lenvatinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-19 (see label)openfda
• Dec 17, 2021Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-17 (see label)openfda
• Dec 16, 2021Brexucabtagene Autoleucel Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TECARTUS (DIN 02516667) under ATC L01XL06 BREXUCABTAGENE AUTOLEUCEL. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Dec 14, 2021Tofacitinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-14 (see label)openfda
• Dec 14, 2021Tofacitinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-14 (see label)openfda
• Dec 10, 2021Ribociclib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-10 (see label)openfda
• Dec 7, 2021Hydroxyurea FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-07 (see label)openfda
• Dec 6, 2021Tafasitamab Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as MINJUVI (DIN 02518627) under ATC L01FX12 TAFASITAMAB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Dec 3, 2021Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-03 (see label)openfda
• Dec 2, 2021Rituximab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-12-02 (see label)openfda
• Dec 2, 2021Fluorouracil Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as FLUOROURACIL INJECTION (DIN 02473763) under ATC L01BC02 FLUOROURACIL. Indications are not published in the Drug Product Database — see…health-canada-dpd
• Nov 30, 2021Carfilzomib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-11-30 (see label)openfda
• Nov 30, 2021Pemigatinib Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as PEMAZYRE (DIN 02519941) under ATC L01EN02 PEMIGATINIB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Nov 26, 2021Pemigatinib Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as PEMAZYRE (DIN 02519968) under ATC L01EN02 PEMIGATINIB. Indications are not published in the Drug Product Database — see the Health Canada…health-canada-dpd
• Nov 22, 2021Sacituzumab Govitecan Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TRODELVY (DIN 02520788) under ATC L01FX17 SACITUZUMAB GOVITECAN. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Nov 22, 2021Zanubrutinib EMA · EU centralised approved cancer not stated in this recordBrukinsa as monotherapy is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior…ema
• Nov 19, 2021Ibuprofen FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-11-19 (see label)openfda
• Nov 18, 2021Ripretinib EMA · EU centralised approved cancer not stated in this recordQinlock is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour (GIST) who have received prior treatment with three or…ema
• Nov 17, 2021Pembrolizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2021-11-17 (see label)openfda

RegulatoryAll 2021 records with filters →

Studies

7,431

Interventional

5,587

Phase III

506

Industry-led

1,742

With posted results

633

Countries with sites

103

Published source: clinicaltrials · first_posted_date as posted