2012 in cancer

FDA · US: 54 records / 33 drugsHealth Canada · CA: 38 records / 15 drugsEMA · EU: 17 records / 12 drugs

• Nov 29, 2012Cabozantinib FDA · US original application approved Thyroid Gland Medullary CarcinomaCOMETRIQ is indicated for the treatment of patients with progressive, metastatic medullary thyroid cancer (MTC). COMETRIQ is a kinase inhibitor indicated for…openfda
• Sep 27, 2012Regorafenib FDA · US original application approved Malignant Colorectal NeoplasmMetastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF…openfda
• Sep 27, 2012Regorafenib FDA · US original application approved Hepatocellular CarcinomaHepatocellular carcinoma (HCC) who have been previously treated with sorafenibopenfda
• Sep 4, 2012Bosutinib FDA · US original application approved Chronic Myeloid Leukemia, Philadelphia Chromosome Negative, BCR-ABL1 Positiveadult and pediatric patients 1 year of age and older with chronic phase Ph+ chronic myelogenous leukemia (CML), newly-diagnosed or resistant or intolerant to…openfda
• Aug 31, 2012Enzalutamide FDA · US original application approved Malignant Prostate Neoplasmnon‑metastatic castration‑sensitive prostate cancer with biochemical recurrence at high risk for metastasis. ( 1 )openfda
• Aug 31, 2012Enzalutamide FDA · US original application approved Nonmetastatic Castration-Sensitive Prostate Carcinomanon‑metastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR) XTANDI is an androgen…openfda
• Aug 31, 2012Enzalutamide FDA · US original application approved Malignant Prostate Neoplasmmetastatic castration-sensitive prostate cancer (mCSPC)openfda
• Aug 31, 2012Enzalutamide FDA · US original application approved Castration-Resistant Prostate Carcinomacastration-resistant prostate cancer (CRPC)openfda
• Aug 31, 2012Enzalutamide FDA · US original application approved Castration-Resistant Prostate Carcinomacastration-resistant prostate cancer. ( 1 )openfda
• Aug 31, 2012Enzalutamide FDA · US original application approved Malignant Prostate Neoplasmmetastatic castration-sensitive prostate cancer. ( 1 )openfda
• Aug 29, 2012Everolimus FDA · US original application approved Renal Cell CarcinomaAdults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.openfda
• Aug 29, 2012Everolimus FDA · US original application approved Primitive Neuroectodermal TumorAdults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine…openfda
• Aug 29, 2012Everolimus FDA · US original application approved Malignant Breast NeoplasmPostmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer in combination with exemestane after failure of treatment with…openfda
• Aug 3, 2012Aflibercept FDA · US original application approved Malignant Colorectal NeoplasmZALTRAP, in combination with fluorouracil, leucovorin, irinotecan-(FOLFIRI), is indicated for the treatment of patients with metastatic colorectal cancer…openfda
• Jul 20, 2012Carfilzomib FDA · US original application approved Multiple MyelomaRelapsed or Refractory Multiple Myeloma Kyprolis is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have…openfda
• Jun 8, 2012Pertuzumab FDA · US original application approved Malignant Breast NeoplasmUse in combination with trastuzumab and docetaxel for treatment of adults with HER2-positive metastatic breast cancer (MBC) who have not received prior…openfda
• Jun 8, 2012Pertuzumab FDA · US original application approved Early Stage Breast CarcinomaUse in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage…openfda
• Jun 8, 2012Pertuzumab FDA · US original application approved Malignant Breast Neoplasmadjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrenceopenfda
• Jan 30, 2012Vismodegib FDA · US original application approved Basal Cell CarcinomaERIVEDGE is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred…openfda
• Jan 27, 2012Axitinib FDA · US original application approved Renal Cell Carcinomaas a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.openfda
• Jan 27, 2012Axitinib FDA · US original application approved Renal Cell Carcinomain combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC).openfda
• Dec 14, 2012Ponatinib FDA · US original application accelerated approved cancer not stated in this recordICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+…openfda
• Dec 14, 2012Pasireotide FDA · US original application approved cancer not stated in this recordCushing's Disease SIGNIFOR is indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been…openfda
• Nov 6, 2012Tofacitinib FDA · US original application approved cancer not stated in this recordModerately to severely active rheumatoid arthritis (RA), who have had an inadequate response or intolerance to one or more TNF blockers. • Active psoriatic…openfda
• Sep 27, 2012Regorafenib FDA · US original application approved cancer not stated in this recordLocally advanced, unresectable or metastatic gastrointestinal stromal tumor (GIST) who have been previously treated with imatinib mesylate and sunitinib malate.openfda
• Sep 4, 2012Bosutinib FDA · US original application approved cancer not stated in this recordAdult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML),…openfda
• Aug 29, 2012Filgrastim FDA · US original application approved cancer not stated in this recordGRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving…openfda
• Aug 29, 2012Everolimus FDA · US original application approved cancer not stated in this recordAdults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery. • AFINITOR and AFINITOR DISPERZ are kinase inhibitors…openfda
• Jun 12, 2012Ibuprofen FDA · US original application approved cancer not stated in this recordUses temporarily relieves minor aches and pains due to: headache toothache backache menstrual cramps the common cold muscular aches minor pain of arthritis…openfda
• Feb 7, 2012Mitomycin FDA · US original application approved cancer not stated in this recordMitosol ® is an antimetabolite indicated for use as an adjunct to ab externo glaucoma surgery. Mitosol ® is an antimetabolite indicated as an adjunct to ab…openfda
• Jan 27, 2012Axitinib FDA · US original application approved cancer not stated in this recordin combination with pembrolizumab, for the first-line treatment of patients with advanced RCC.openfda
• Oct 25, 2012Brentuximab Vedotin EMA · EU centralised approved Primary Cutaneous T-Cell Non-Hodgkin LymphomaHodgkin lymphomaAdcetris is indicated for adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma (HL) in combination with doxorubicin,…ema
• Sep 20, 2012Decitabine EMA · EU centralised approved Secondary Acute Myeloid LeukemiaTreatment of adult patients with newly diagnosed de novo or secondary acute myeloid leukaemia (AML), according to the World Health Organization (WHO)…ema
• Sep 3, 2012Axitinib EMA · EU centralised approved Renal Cell CarcinomaInlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.ema
• Mar 9, 2012Mercaptopurine EMA · EU centralised approved Acute Lymphoblastic LeukemiaXaluprine is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in adults, adolescents and children.ema
• Feb 17, 2012Vemurafenib EMA · EU centralised approved MelanomaVemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.ema
• Feb 16, 2012Vandetanib EMA · EU centralised approved Thyroid Gland Medullary CarcinomaCaprelsa is indicated for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or…ema
• Dec 20, 2012Nilotinib FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2012-12-20 (see label)openfda
• Dec 10, 2012Abiraterone Acetate FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2012-12-10 (see label)openfda
• Dec 10, 2012Abiraterone FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2012-12-10 (see label)openfda
• Nov 22, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as PRO-ANASTROZOLE (DIN 02395649) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the Health…health-canada-dpd
• Nov 19, 2012Capecitabine EMA · EU centralised approved cancer not stated in this recordCapecitabine Medac is indicated for the adjuvant treatment of patients following surgery of stage-III (Dukes’ stage-C) colon cancer. Capecitabine Medac is…ema
• Nov 18, 2012Ibandronic Acid EMA · EU centralised approved cancer not stated in this recordIbandronic acid is indicated in adults for Prevention of skeletal events (pathological fractures, bone complications requiring radiotherapy or surgery) in…ema
• Nov 9, 2012Fulvestrant FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2012-11-09 (see label)openfda
• Nov 7, 2012Temozolomide Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02395274) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Nov 7, 2012Temozolomide Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02395282) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Nov 7, 2012Temozolomide Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02395290) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Nov 7, 2012Temozolomide Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TEVA-TEMOZOLOMIDE (DIN 02395312) under ATC L01AX03 TEMOZOLOMIDE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Oct 26, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as RIVA-ANASTROZOLE (DIN 02392259) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Oct 26, 2012Bevacizumab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2012-10-26 (see label)openfda
• Oct 25, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as APO-ANASTROZOLE (DIN 02374420) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the Health…health-canada-dpd
• Oct 25, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as MAR-ANASTROZOLE (DIN 02379562) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the Health…health-canada-dpd
• Oct 25, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TEVA-ANASTROZOLE (DIN 02394898) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Oct 25, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as MINT-ANASTROZOLE (DIN 02393573) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Oct 25, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as PMS-ANASTROZOLE (DIN 02320738) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the Health…health-canada-dpd
• Oct 25, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as JAMP-ANASTROZOLE (DIN 02339080) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Oct 25, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as TARO-ANASTROZOLE (DIN 02365650) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the…health-canada-dpd
• Oct 25, 2012Anastrozole Health Canada · CA DIN approved cancer not stated in this recordMarketed in Canada as ACH-ANASTROZOLE (DIN 02351218) under ATC L02BG03 ANASTROZOLE. Indications are not published in the Drug Product Database — see the Health…health-canada-dpd
• Oct 23, 2012Crizotinib EMA · EU centralised approved cancer not stated in this recordXalkori as monotherapy is indicated for: The first line treatment of adults with anaplastic lymphoma kinase (ALK) positive advanced non small cell lung cancer…ema
• Oct 19, 2012Rituximab FDA · US supplement approved cancer not stated in this recordEfficacy supplement 2012-10-19 (see label)openfda

RegulatoryAll 2012 records with filters →

Studies

3,887

Interventional

3,150

Phase III

389

Industry-led

915

With posted results

1,014

Countries with sites

96

Published source: clinicaltrials · first_posted_date as posted