Items Tagged ‘Breakthrough Therapy Designation’

September 6th, 2016

FDA Accepts Priority Review of Rucaparib For The Treatment Of Advanced Mutant BRCA Ovarian Cancer

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The U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for accelerated approval of rucaparib and granted priority review status to the application for the treatment of advanced ovarian cancer in patients with deleterious BRCA-mutated cancers. Rucaparib was granted Breakthrough Therapy Designation by the FDA in April 2015. About Ovarian Cancer […]

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Tags: Breakthrough Therapy Designation, News, Ovarian Cancer, PARP1, PARP2, PARP3, Stage II-IV Ovarian Cancer


August 9th, 2016

Pracinostat Receives Breakthrough Therapy Designation from FDA for Treatment in Combination with Azacitidine of Patients with Newly Diagnosed Acute Myeloid Leukemia

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The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational drug Pracinostat in combination with azacitidine for the treatment of elderly patients with newly diagnosed acute myeloid leukemia (AML). Acute myeloid leukemia (AML) is a cancer of the bone marrow (spongy portion found in the middle of bones) and blood […]

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Tags: Acute Myeloid Leukemia, AML, azacitidine, Breakthrough Therapy Designation, elderly, FDA. BTD, HDACs, Leukemia, News, Pracinostat


July 19th, 2016

Loxo Oncology Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for LOXO-101

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Loxo Oncology, Inc. (LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK), “for the treatment of unresectable or metastatic solid tumors with NTRK-fusion […]

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Tags: All Cancer Types, Breakthrough Therapy Designation, FDA. BTD, General, LOXO-101, metastatic solid tumors, News, TRK fusions, unresectable


May 25th, 2016

More Evidence that PD-1 Inhibitors Improve Survival in Head and Neck Cancer

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Results from a recent large trial indicate that treatment with the immunotherapy agent Opdivo® (nivolumab) nearly doubles the survival rate at one year in patients with advanced head and neck squamous cell carcinoma. These results prompted the United States Food and Drug Administration to grant Opdivo “breakthrough therapy designation” for the treatment of patients with […]

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Tags: Breakthrough Therapy Designation, CheckMate 141 clinical trial, fda, General Head and Neck Cancer, Head and Neck Cancer, News, nivolumab, opdivo, squamous cell


February 26th, 2015

FDA Grants Breakthrough Therapy Designation for MPDL3280A, an anti-PDL1 Investigational Cancer Immunotherapy for Non-Small Cell Lung Cancer

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The investigational cancer immunotherapy MPDL3280A (anti-PDL1) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA). The designation was granted for the treatment of people with PD-L1 (Programmed Death-Ligand 1) positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy. Lung cancer remains the leading cause of […]

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Tags: anti-PDL1, Breakthrough Therapy Designation, Lung Cancer, Lung Cancer - Non-Small Cell, MPDL3280A, News, non-small cell lung cancer, nsclc, PDL1, Recurrent Lung Cancer - Non-Small Cell, Stages IIIB-IV Lung Cancer - Non-Small Cell