FDA Grants Atezolizumab Regimen Priority Review for Frontline SCLC
December 5th 2018The FDA has granted a priority review designation to a supplemental biologics license application for atezolizumab for use in combination with carboplatin and etoposide for the frontline treatment of patients with extensive-stage small cell lung cancer.
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Daratumumab Plus Rd New Frontline Standard in Transplant-Ineligible Myeloma
December 4th 2018The triplet of daratumumab, lenalidomide, and dexamethasone reduced the risk of disease progression or death by 44% compared with lenalidomide plus dexamethasone in newly diagnosed patients with multiple myeloma who were not candidates for high-dose chemotherapy and autologous stem-cell transplant.
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Lenalidomide/Rituximab Improves PFS in Indolent Non-Hodgkin Lymphoma
December 3rd 2018The R2 regimen of lenalidomide (Revlimid) plus rituximab (Rituxan) reduced the risk of disease progression or death by 54% versus rituximab alone in patients with relapsed/refractory indolent non-Hodgkin lymphoma.
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Ibrutinib Established as Standard for Older CLL Patients
December 2nd 2018Ibrutinib as monotherapy and combined with rituximab significantly improved progression-free survival compared with bendamustine plus rituximab as frontline therapy for older patients with chronic lymphocytic leukemia.
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FDA Approves Glasdegib for Frontline AML
November 21st 2018The FDA has approved glasdegib for use in combination with low-dose cytarabine for the treatment of patients with newly-diagnosed acute myeloid leukemia who are aged 75 years or older or who are ineligible for intensive chemotherapy.
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FDA Approves Frontline Venetoclax in AML
November 21st 2018The FDA has granted an accelerated approval to venetoclax for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of adult patients with newly-diagnosed acute myeloid leukemia (AML) who are aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
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Novel Agent Active Across Heavily Pretreated HER2+ Tumors
November 17th 2018The novel bispecific antibody ZW25 induced a disease control rate of 82% in heavily pretreated patients across several HER2-positive tumor types, according to phase I study results presented at the 2018 EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Symposium.
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Blinatumomab Approaches European Approval for MRD+ ALL
November 17th 2018The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of blinatumomab for the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia who are in remission but still have minimal residual disease of at least 0.1%.
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Durvalumab Combo Misses OS Endpoint in Frontline Metastatic NSCLC
November 16th 2018The frontline combination of durvalumab (Imfinzi) and tremelimumab did not induce a statistically significant improvement in overall survival compared to standard chemotherapy in patients with metastatic non–small cell lung cancer.
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FDA Grants Brentuximab Vedotin Breakthrough Designation for Frontline CD30+ PTCL
November 16th 2018The FDA has granted brentuximab vedotin a breakthrough therapy designation for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
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FDA Grants Atezolizumab Combo Priority Review for Frontline TNBC
November 13th 2018The FDA has granted a priority review designation to a supplemental biologics license application for the frontline combination of atezolizumab plus nab-paclitaxel for patients with unresectable locally advanced or metastatic PD-L1–positive triple-negative breast cancer.
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FDA Grants Olaparib Priority Review for Frontline Maintenance in Ovarian Cancer
November 12th 2018The FDA has granted a priority review designation to a supplemental new drug application for olaparib tablets for use as a maintenance therapy in patients with newly-diagnosed, BRCA-positive advanced ovarian cancer who achieved a complete or partial response to standard frontline platinum-based chemotherapy.
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FDA Approves Elotuzumab Triplet for Myeloma
November 7th 2018The FDA has approved elotuzumab for use in combination with pomalidomide and low-dose dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma following 2 or more prior therapies, including lenalidomide and a proteasome inhibitor.
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FDA Approval Sought for Brentuximab Vedotin in Frontline CD30+ PTCL
November 6th 2018A supplemental biologics license application has been submitted to the FDA for the use of brentuximab vedotin (Adcetris) in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma.
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Daratumumab Plus Lenalidomide/Dexamethasone Improves PFS in Frontline Myeloma Trial
October 30th 2018Adding daratumumab to lenalidomide and dexamethasone reduced the risk of disease progression or death by 45% compared with lenalidomide/dexamethasone alone in newly diagnosed patients with multiple myeloma who are not candidates for high-dose chemotherapy and autologous stem-cell transplant.
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FDA Grants Priority Review to Ruxolitinib for GVHD
October 26th 2018The FDA has granted a priority review designation to a supplemental new drug application for ruxolitinib (Jakafi) for the treatment of patients with acute graft-versus-host disease who have had an inadequate response to corticosteroids.
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FDA Extends Review Period for Frontline Nivolumab/Ipilimumab in TMB-High NSCLC
October 22nd 2018The FDA has added 3 months to the review period for the combination of nivolumab plus low-dose ipilimumab for the frontline treatment of patients with advanced non–small cell lung cancer with tumor mutational burden ≥10 mutations per megabase.
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