FDA Recommends No NDA for Tivozanib in RCC
February 1st 2019The FDA has recommended that Aveo Oncology should not submit a new drug application for tivozanib with the preliminary overall survival data from the phase III TIVO-3 trial of patients with highly refractory, advanced or metastatic renal cell carcinoma.
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FDA Expands Pemetrexed Approval for Frontline Pembrolizumab/Chemo Combo in NSCLC
January 31st 2019The FDA has expanded the indication for pemetrexed in combination with pembrolizumab and platinum-based chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer without EGFR or ALK alterations.
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Apalutamide Improves Survival in Metastatic Castration-Sensitive Prostate Cancer
January 31st 2019Apalutamide (Erleada) in combination with androgen deprivation therapy was found to significantly improve radiographic progression-free survival and overall survival versus placebo in patients with metastatic castration-sensitive prostate cancer.
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CDK4/6 Inhibitors, Alpelisib Continue to Show Benefit in HR+/HER2- Breast Cancer
January 30th 2019Kevin Kalinsky, MD, MS, highlights the recent data with alpelisib and CDK4/6 inhibitors, the toxicity differences between the 3 available CDK4/6 agents, and the next steps for both classes of agents.
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European Commission Approves Maintenance Rucaparib in Ovarian Cancer
January 25th 2019The European Commission has approved an expanded indication for 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, regardless of BRCA status.
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BMS Withdraws Application for Nivolumab/Ipilimumab in TMB-High NSCLC
January 24th 2019Bristol-Myers Squibb has withdrawn its supplemental biologics license application for the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the frontline treatment of patients with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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Ibrutinib Combo Falls Short in Pancreatic Cancer
January 22nd 2019The frontline combination of ibrutinib (Imbruvica) and nab-paclitaxel (Abraxane)/gemcitabine did not show a statistically significant benefit in progression-free or overall survival versus placebo plus nab-paclitaxel/gemcitabine in patients with metastatic pancreatic cancer.
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Olaratumab Falls Short in Phase III Soft Tissue Sarcoma Trial
January 18th 2019Olaratumab in combination with doxorubicin missed the phase III ANNOUNCE trial’s primary endpoint of overall survival and did not confirm a clinical benefit for patients with advanced or metastatic soft tissue sarcoma compared with standard doxorubicin.
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FDA Issues Complete Response Letter for Sacituzumab Govitecan in TNBC
January 18th 2019The FDA has issued a complete response letter to Immunomedics regarding its biologics license application for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer who have received at least 2 prior therapies, citing chemistry, manufacturing, and control matters.
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FDA Issues Letter Regarding Safety Concerns With Paclitaxel-Coated Devices
January 18th 2019The FDA has issued a letter to healthcare providers that they should monitor patients with a type of peripheral arterial disease who have been treated with vascular balloons that were coated with paclitaxel or stents that release paclitaxel in the femoropopliteal artery in the leg.
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FDA Accepts sBLA for Frontline Atezolizumab Plus Carboplatin/Nab-Paclitaxel in Nonsquamous NSCLC
January 17th 2019The FDA has accepted a supplemental biologics license application for atezolizumab, carboplatin, and nab-paclitaxel as a first-line treatment for patients with metastatic nonsquamous non–small cell lung cancer.
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FDA Grants Zanubrutinib Breakthrough Designation for Mantle Cell Lymphoma
January 15th 2019The FDA has granted the investigational BTK inhibitor zanubrutinib a breakthrough therapy designation for the treatment of adult patients with mantle cell lymphoma who have previously received at least 1 prior therapy.
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Varlitinib Misses Primary Endpoint in Frontline Gastric Cancer Trial
January 14th 2019Frontline varlitinib (ASLAN001) added to mFOLFOX6 was not found to significantly reduce tumor size after 12 weeks of therapy compared with mFOLFOX6 alone in patients with HER1/HER2 co-expressing advanced or metastatic gastric cancer, missing the primary endpoint of a phase II study.
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