Nivolumab Improves OS in Advanced or Recurrent Esophageal Cancer
January 10th 2019Nivolumab demonstrated a significant extension in overall survival versus chemotherapy in patients with unresectable advanced or recurrent esophageal cancer that is refractory to or intolerant of fluoropyrimidine plus platinum-based therapy.
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Pembrolizumab Granted 5 Additional Approvals in Japan
January 3rd 2019The Japan Pharmaceuticals and Medical Devices Agency has approved pembrolizumab for 5 new indications, including melanoma, advanced microsatellite instability-high tumors, and 3 expanded uses in advanced non–small cell lung cancer.
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FDA Approves Longer-Acting Calaspargase Pegol-mknl for ALL
December 21st 2018The FDA has approved a longer-acting version of calaspargase pegol-mknl (Asparlas) as a component of a multiagent chemotherapy regimen for pediatric and young adult patients aged 1 month to 21 years with acute lymphoblastic leukemia.
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Olaparib Succeeds in Confirmatory Trial for Relapsed BRCA+ Ovarian Cancer
December 20th 2018The PARP inhibitor olaparib demonstrated a statistically significant and clinically meaningful improvement in objective response rate in patients with BRCA-mutant ovarian cancer who have relapsed on at least 2 prior lines of therapy.
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FDA Approves Olaparib for Frontline Maintenance in Ovarian Cancer
December 20th 2018The FDA has approved olaparib as a maintenance treatment for patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to frontline platinum-based chemotherapy.
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Neratinib Improves PFS in HER2+ Metastatic Breast Cancer
December 19th 2018Neratinib led to a statistically significant improvement in centrally confirmed progression-free survival compared with lapatinib and capecitabine in patients with HER2-positive metastatic breast cancer who have failed 2 or more prior lines of HER2-directed therapy.
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EU Panel Backs Dasatinib for Pediatric Ph+ ALL
December 17th 2018The European Medicines Agency's Committee for Medicinal Products for Human Use has granted a positive opinion to dasatinib in combination with chemotherapy for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
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EU Panel Backs Maintenance Rucaparib for Ovarian Cancer
December 14th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended to expand the approval of single-agent rucaparib as a maintenance therapy in adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.
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Phase III Rova-T Trial Halted in Small Cell Lung Cancer
December 7th 2018The phase III TAHOE trial evaluating second-line rovalpituzumab tesirine as a treatment for patients with advanced small cell lung cancer has stopped enrollment as recommended by an Independent Data Monitoring Committee.
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No Survival Benefit With Adjuvant Capecitabine in Early-Stage TNBC
December 6th 2018Adjuvant treatment with capecitabine in patients with early-stage triple-negative breast cancer did not significantly improve disease-free or overall survival compared with observation, according to results from the phase III GEICAM/CIBOMA trial that were presented at the 2018 San Antonio Breast Cancer Symposium.
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Phase III Data Showcase PFS Benefit With Frontline Ibrutinib/Obinutuzumab Combo in High-Risk CLL
December 4th 2018The first-line combination of ibrutinib (Imbruvica) and obinutuzumab (Gazyva) was associated with a 77% reduction in the risk for disease progression or death compared with chemoimmunotherapy in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.
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Liso-Cel Demonstrates Durable Responses in Heavily Pretreated, High-Risk CLL
December 3rd 2018Lisocabtagene maraleucel appeared tolerable and induced an 81.3% best overall response rate and 43.8% complete response rate in heavily pretreated, high-risk patients with chronic lymphocytic leukemia who previously received ibrutinib.
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Maintenance Ixazomib Extends PFS in Newly Diagnosed Multiple Myeloma
December 3rd 2018Two-year maintenance therapy with ixazomib led to a 39% improvement in progression-free survival compared with placebo in patients with newly diagnosed multiple myeloma who achieved a partial response to induction treatment with a proteasome inhibitor and/or an immunomodulatory agent following autologous stem cell transplant.
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Ibrutinib/CAR T Cell Combo Active in CLL
December 2nd 2018Concurrent treatment with ibrutinib and the CD19-targeted chimeric antigen receptor T-cell therapy JCAR014 was well tolerated and led to an overall response rate of 83% in patients with relapsed or refractory chronic lymphocytic leukemia.
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Pegfilgrastim Biosimilar Approved in Europe
November 28th 2018The European Commission has granted approval to the biosimilar Ziextenzo, a biosimilar for pegfilgrastim, as a treatment to reduce the duration of neutropenia and incidence of febrile neutropenia that is associated with anticancer chemotherapy.
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