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FDA Approves Empliciti Regimen to Treat Relapsed or Refractory Myeloma
November 7th 2018The Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for use in combination with Pomalyst (pomalidomide) and low-dose dexamethasone, also known as EPd, for the treatment of patients with relapsed/refractory multiple myeloma following two or more prior therapies, including Revlimid (lenalidomide) and a proteasome inhibitor.
Combination with Higher Dose of Yervoy Shows Promise in Bladder Cancer
November 6th 2018Patients with platinum-pretreated metastatic urothelial carcinoma who were treated with a higher dosage of Yervoy (ipilimumab) in combination with Opdivo (nivolumab) experienced improved survival and tolerable side effects, according to findings from the phase 1/2 CheckMate-032 trial.
FDA Approves Lorbrena for Metastatic Non-Small Cell Lung Cancer Subtype
November 3rd 2018The Food and Drug Administration (FDA) granted accelerated approval to Lorbrena (lorlatinib) for the treatment of patients with ALK-positive, metastatic non-small cell lung cancer (NSCLC) who progressed on one or more ALK tyrosine kinase inhibitor (TKI), according to Pfizer, the drug’s manufacturer.
Maintenance Lynparza Improves PFS for Ovarian Cancer
October 30th 2018The PARP inhibitor Lynparza (olaparib) significantly improved progression-free survival (PFS) as frontline maintenance therapy for women with BRCA-positive advanced ovarian cancer, according to findings from the randomized phase 3 SOLO-1 trial presented at the 2018 ESMO Congress.
FDA Grants Priority Review to Jakafi for Acute Graft-Versus-Host-Disease
October 26th 2018The Food and Drug Administration has granted a priority review to the supplemental new drug application for Jakafi (ruxolitinib) to treat patients with acute graft-versus-host-disease (GVHD) who have had an inadequate response to corticosteroids.
FDA Grants Priority Review to Lonsurf for Gastric Adenocarcinoma
October 26th 2018The Food and Drug Administration (FDA) has granted a priority review to a supplemental new drug application for Lonsurf (TAS-102; trifluridine/tipiracil) for use in previously treated patients with advanced or metastatic gastric adenocarcinoma, including cancer of the gastroesophageal junction.