Lenalidomide/Rituximab Data Published as FDA Weighs Non-Hodgkin Lymphoma Approval
April 9th 2019The R2 regimen of lenalidomide plus rituximab significantly reduced the risk of disease progression or death compared with rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma, according to results from the pivotal phase III AUGMENT trial.
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FDA Extends Review Period for Quizartinib in AML
April 4th 2019The FDA has added 3 months to the review period for a new drug application for quizartinib for the treatment of adult patients with relapsed/refractory FLT3-ITD–positive acute myeloid leukemia, allowing the agency to review additional data provided by Daiichi Sankyo.
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Enfortumab Vedotin Active After Chemo and Immunotherapy in Urothelial Carcinoma
March 28th 2019Enfortumab vedotin showed strong clinical activity in patients with locally advanced or metastatic urothelial carcinoma who previously received both platinum-containing chemotherapy and immune checkpoint therapy, according to topline results from the pivotal phase II EV-201 trial.
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Rolling Submission Completed for Daratumumab/Rd in Frontline Transplant-Ineligible Myeloma
March 13th 2019A supplemental biologics license application has been submitted to the FDA for the approval of daratumumab in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
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EU Panel Backs Lorlatinib for ALK+ NSCLC
March 1st 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of lorlatinib for the treatment of adult patients with ALK-positive advanced non–small cell lung cancer whose disease has progressed after alectinib or ceritinib as the first ALK TKI, or crizotinib and at least one other ALK TKI.
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FDA Panel Votes Against Accelerated Approval of Selinexor for Myeloma
February 27th 2019The FDA’s Oncologic Drugs Advisory Committee voted against accelerated approval of a new drug application for selinexor for the treatment of patients with penta-refractory multiple myeloma, recommending delaying a decision on the drug until results are available from the pivotal phase III BOSTON trial.
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FDA Grants Lenalidomide/Rituximab Priority Review for Indolent Non-Hodgkin Lymphoma
February 27th 2019The FDA has granted a priority review designation to a supplemental new drug application for the R2 regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) for use in patients with previously treated follicular lymphoma and marginal zone lymphoma.
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FDA Approves TAS-102 for Gastric/GEJ Cancer
February 25th 2019The FDA has approved TAS-102 (trifluridine/tipiracil; Lonsurf) for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least 2 prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy.
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FDA Grants Ivosidenib Priority Review for Frontline IDH1+ AML
February 21st 2019The FDA has granted a priority review to a supplemental new drug application for ivosidenib for the frontline treatment of patients IDH1-mutant acute myeloid leukemia who are ineligible for standard chemotherapy.
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Nivolumab/Ipilimumab OS Benefit Sustained in Long-Term Follow-Up for Frontline RCC
February 13th 2019Nivolumab combined with low-dose ipilimumab continued to demonstrate strong responses and a survival benefit at 30 months’ follow-up as a frontline treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma.
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LuPSMA May Improve Survival in Heavily Pretreated mCRPC
February 12th 2019The novel targeted radiation therapy lutetium-177 PSMA-617 showed strong clinical activity and the potential to improve survival in heavily pretreated men with PSMA-positive metastatic castration-resistant prostate cancer.
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FDA Extends Review Period for Ruxolitinib in GVHD
February 8th 2019The FDA has added 3 months to the review period for a supplemental new drug application for ruxolitinib for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids, making the new action date May 24, 2019.
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FDA Approval Sought for Adjuvant T-DM1 in High-Risk HER2+ Breast Cancer
February 5th 2019Genentech has completed its FDA submission of a supplemental Biologics License Application for ado-trastuzumab emtansine as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual disease following neoadjuvant therapy.
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Dacomitinib Approaches EU Approval for EGFR+ NSCLC
February 2nd 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of dacomitinib for the frontline treatment of adult patients with metastatic non–small cell lung cancer with EGFR-activating mutations.
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FDA Approval Sought for Daratumumab/Rd for Frontline Transplant-Ineligible Myeloma
January 22nd 2019A supplemental Biologics License Application (sBLA) has been initiated with the FDA for daratumumab (Darzalex) for use in combination with lenalidomide (Revlimid) and dexamethasone (DRd) for the treatment of certain patients with multiple myeloma.
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FDA Delays Decision on Frontline Pembrolizumab sBLA in NSCLC
December 21st 2018The FDA has extended the review period for a supplemental biologics license application for single-agent pembrolizumab for the frontline treatment of patients with locally advanced or metastatic nonsquamous or squamous non–small cell lung cancer with a PD-L1 expression level of ≥1% and no EGFR or ALK genomic tumor aberrations.
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EU Panel Backs Brentuximab Vedotin for Frontline CD30+ Hodgkin Lymphoma
December 15th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of brentuximab vedotin for use in combination with chemotherapy as a frontline treatment for adult patients with CD30+ stage IV Hodgkin lymphoma.
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Durvalumab Falls Short in Head and Neck Cancer
December 8th 2018Durvalumab alone and in combination with tremelimumab did not improve overall survival versus standard-of-care chemotherapy in patients with recurrent or metastatic head and neck squamous cell carcinoma who progressed after platinum-based chemotherapy.
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T-DM1 Likely New Adjuvant Standard in High-Risk HER2+ Breast Cancer
December 6th 2018Ado-trastuzumab emtansine reduced the risk of invasive disease recurrence or death by 50% compared with trastuzumab as an adjuvant treatment for patients with HER2-positive early breast cancer who had residual invasive disease following neoadjuvant therapy.
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