Impressive Upfront Palbociclib PFS Benefit Confirmed in ER+/HER2- Breast Cancer
June 7th 2016Adding the CDK 4/6 inhibitor palbociclib (Ibrance) to letrozole reduced the risk of disease progression by 42% compared with letrozole alone in patients with ER-positive, HER2-negative advanced or metastatic breast cancer.
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Long-Term Follow-up Sustains Frontline Nivolumab/Ipilimumab Benefit in Melanoma
June 7th 2016At a minimum follow-up of 18 months, the combination of nivolumab and ipilimumab reduced the risk of disease progression by 58% compared with ipilimumab alone, and single-agent nivolumab lowered the risk of progression by 45% versus ipilimumab monotherapy in patients with advanced melanoma.
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Nivolumab/Ipilimumab Combo Active in Microsatellite Instability-High mCRC
June 6th 2016Nivolumab (Opdivo) as a monotherapy and in combination with ipilimumab (Yervoy) demonstrated promising antitumor activity in patients with high microsatellite instability (MSI-H) metastatic colorectal cancer.
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Nivolumab Survival Benefit Sustained in Long-Term NSCLC Outcomes
June 5th 2016Two-year follow-up data showed sustained improvements in overall survival with nivolumab in pretreated patients with either nonsquamous or squamous non–small cell lung cancer in updated findings from the phase III CheckMate-057 and -017 trials.
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Despite ASCO Mishap, Data Still Intriguing for Sacituzumab Govitecan in TNBC
June 4th 2016Sacituzumab govitecan (IMMU-132) had an objective response rate of 33% in pretreated patients with triple-negative breast cancer, according to updated findings from a phase II study reported by Immunomedics, the manufacturer of the antibody-drug conjugate.
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CHMP Backs New Brentuximab Vedotin Indication for Hodgkin Lymphoma
May 28th 2016The EMA's Committee for Medicinal Products for Human Use has granted a positive opinion to brentuximab vedotin (Adcetris) for use as a consolidation therapy following autologous stem cell transplantation in patients with CD30-positive Hodgkin lymphoma at risk of relapse or progression.
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CHMP Recommends Expanding Carfilzomib Approval in Multiple Myeloma
May 27th 2016Carfilzomib (Kyprolis) has received a positive recommendation from the EMA's Committee for Medicinal Products for Human Use for use in combination with dexamethasone alone as a treatment for patients with multiple myeloma following at least 1 prior therapy.
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Daratumumab Approved in Europe for Multiple Myeloma
May 23rd 2016The European Commission has granted conditional marketing approval to daratumumab (Darzalex) for the treatment of patients with relapsed/refractory multiple myeloma previously treated with a proteasome inhibitor and an immunomodulatory agent who progressed on their last therapy.
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Long-Term Data Uphold Neoadjuvant Pertuzumab Benefit in HER2+ Breast Cancer
May 19th 2016A 5-year follow-up of the phase II NeoSphere trial confirmed that patients with HER2-positive breast cancer receiving a 3-drug neoadjuvant pertuzumab regimen had better outcomes compared with patients receiving trastuzumab and docetaxel.
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Tumor Location Linked to Survival Outcomes in Metastatic Colorectal Cancer
May 19th 2016Survival outcomes in patients with metastatic colorectal cancer were significantly longer among those with tumors originating on the left versus the right side of the colon, according to a retrospective analysis of the phase III 80405 trial.
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FDA Approves Atezolizumab in Bladder Cancer
May 18th 2016The FDA granted the PD-L1 inhibitor atezolizumab (Tecentriq) an accelerated approval as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease progressed during or after platinum-based chemotherapy, or within 12 months of receiving platinum-based chemotherapy, either before or after surgery.
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FDA Approves Nivolumab for Hodgkin Lymphoma
May 17th 2016The FDA approved nivolumab (Opdivo) for the treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and posttransplantation brentuximab vedotin (Adcetris).
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Combined Vaccines Study Misses Primary Endpoint in Pancreatic Cancer
May 16th 2016A regimen combining the vaccines CRS-207 and GVAX Pancreas failed to improve overall survival versus either CRS-207 alone or chemotherapy in patients with metastatic pancreatic cancer who had failed at least 2 prior therapies.
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FDA Updates Ibrutinib CLL Label With New OS, Combo Data
May 9th 2016The FDA has expanded the label of ibrutinib (Imbruvica) to include overall survival results in treatment-naive patients with chronic lymphocytic leukemia, as well as outcomes with the BTK inhibitor when combined with bendamustine and rituximab in relapsed/refractory patients with CLL.
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