Items Tagged ‘fda’

November 29th, 2016

Darzalex® Approved for Additional Indications in Multiple Myeloma

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The United States Food and Drug Administration (FDA) has approved Darzalex® (daratumumab) for the treatment of multiple myeloma among patients who have received at least one prior therapy. The new FDA indication also requires that daratumumab be used in combination with lenalidomide and dexamethasone, or in combination with bortezomib and dexamethasone. Daratumumab is already approved […]

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Tags: blood cancer, bortezomib, CASTOR, CD38, Darzalex, dexamethasone, fda, lenalidomide, Multiple Myeloma, News, POLLUX, Recurrent Multiple Myeloma


November 28th, 2016

Opdivo Approved for Advanced Head and Neck Cancer

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The United States Food and Drug Administration (FDA) has approved the immunotherapeutic agent, Opdivo® (nivolumab) for the treatment of advanced head and neck cancer. Specifically,  the indication is for the treatment of squamous cell carcinoma of the head and neck cancer (SCCHN) that has spread to distant sites in the body and has progressed or […]

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Tags: fda, General Head and Neck Cancer, Head and Neck Cancer, News, nivolumab, opdivo, schhn


November 17th, 2016

FDA Priority Review Granted for Midostaurin in Leukemia

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The United States Food and Drug Administration (FDA) has granted priority review to PKC412 (midostaurin) in the treatment of newly diagnosed acute myeloid leukemia (AML) with the FLT3 mutation, as well as for the treatment of advanced systemic mastocytosis (SM). The diagnostic test to detect the FLT3 mutation has also been accepted for review by […]

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Tags: Acute Myeloid Leukemia, AML, fda, FLT3 mutation, itchy skin, Leukemia, mast cell, mastocytosis, midostaurin, News, PKC412


October 25th, 2016

Keytruda Approved for First-Line Treatment of Select Patients with Advanced Non-Small Cell Lung Cancer

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The US Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab) as a first-line treatment options for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express high levels of PD-L1 without EGFR or ALK mutations. PD-1 is a protein that inhibits certain types of immune responses. Drugs that block PD-1, such as Keytruda […]

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Tags: fda, keytruda, Lung Cancer, Lung Cancer - Non-Small Cell, News, non-small cell lung cancer, nsclc, Recurrent Lung Cancer - Non-Small Cell, Stages IIIB-IV Lung Cancer - Non-Small Cell


September 7th, 2016

Keytruda® Approved for Advanced Head and Neck Cancer

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The United States Food and Drug Administration (FDA) has approved Keytruda® (pembrolizumab) for the treatment of advanced head and neck cancer that has stopped responding to platinum-based chemotherapy agents.1 Globally, head and neck cancer comprises the seventh most common type of cancer with an estimated 400,000-600,000 diagnoses every year. Head and neck squamous cell cancer […]

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Tags: advanced, fda, General Head and Neck Cancer, Head and Neck Cancer, keytruda, metastatic, News, pembrolizumab


July 18th, 2016

FDA Places Hold on a Trial Evaluating Genetically Engineered Immune Cells for Cancer Treatment

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The United States Food and Drug Administration (FDA) has placed a hold on a clinical trial, referred to as the ROCKET trial, due to side effects of the treatment that may be associated with 3 patient deaths. Chimeric antigen receptor (CAR) technology is an emerging treatment technique that has demonstrated significant effectiveness in the treatment […]

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Tags: Adult Acute Lymphoblastic Leukemia, B cell acute lymphoblastic leukemia, CAR technology, Clinical Trials Database, deaths, fda, Fludara, fludarabine, Leukemia, News, ROCKET trial


June 6th, 2016

PD-1 Inhibitor Keytruda® Combined with Chemotherapy Promising in Lung Cancer Will be Evaluated in Larger Clinical Trials

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According to experts at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting in Chicago, new data evaluating Keytruda® (pembrolizumab) in combination with chemotherapy appears promising for the treatment of non-small cell lung cancer (NSCLC). Based on these initial results, two comparative clinical trials have been initiated. The programmed death (PD-1) inhibitor Keytruda (pembrolizumab) […]

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Tags: fda, immunotherapy, KEYNOTE-189, keytruda, Lung Cancer, Lung Cancer - Non-Small Cell, News, non-small cell lung cancer, nsclc, PD-1 inhibitor, pembrolizumab


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


May 24th, 2016

Lenvima® Approved for Kidney Cancer

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The United States Food and Drug Administration (FDA) has approved Lenvima® (lenvatinib) for the treatment of kidney cancer. The approval is for patients with advanced renal cell carcinoma who have received at least one prior therapy with an anti-angiogenic agent, and is to be used in combination with the standard agent Afinitor® (everolimus). Each year […]

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Tags: afinitor, everolimus, fda, General Renal Cancer, kidney cancer, lenvatinib, Lenvima, News, rcc, Renal Cancer, RTK


May 23rd, 2016

Genetically Modified Poliovirus Granted “Breakthrough” by FDA for Glioblastoma

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The United States Food and Drug Administration (FDA) has granted “breakthrough status” designation for the treatment of glioblastoma containing a genetically modified poliovirus. Glioblastoma is an extremely aggressive form of brain cancer, with few patients surviving 5 years following diagnosis. Despite efforts with surgery, chemotherapy, and/or radiation therapy, the overall outcomes for patients with glioblastoma […]

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Tags: Brain Cancer, breakthrough status, fda, General Brain Cancer, genetically modified polio virus, glioblastoma, immunotherapy, News


May 2nd, 2016

EPI proColon® – Novel Blood Screening Test Approved for Colorectal Cancer Detection

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The United States Food and Drug Administration (FDA) has approved Epi proColon®, a test that screens for colorectal cancer from a simple blood draw. The approval specifies that EPI proColon is only indicated for individuals at an average risk of developing colorectal cancer who choose not to undergo other colorectal cancer screening methods specified in […]

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Tags: approval, Colon Cancer, colorectal cancer, EPI proColon, fda, News, non-invasive, Rectal Cancer, risk, screening, Screening/Prevention Colon Cancer, Screening/Prevention Rectal Cancer


April 27th, 2016

Pacritinib Development in Myelofibrosis Placed on Clinical Hold by the FDA

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The investigative agent, pacritinib, being evaluated for treatment of myelofibrosis has been placed on full clinical hold by the United States Food and Drug Administration (FDA). All trials including treatment involving pacritinib have been stopped, and the New Drug Application (NDA) to the FDA for pacritinib has been withdrawn.1 Myelofibrosis is a type of blood […]

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Tags: clinical hold, fda, mpn, myelofibrosis, myeloproliferative neoplasm, Myeloproliferative Neoplasms MPN, NDA, News, pacritinib, withdrawn


March 17th, 2016

Ibrance® Approved for Use in Combination with Faslodex® in Hormone-Positive Breast Cancer

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The United States Food and Drug Administration (FDA) has approved Ibrance (palbociclib) to be used with Faslodex (fulvestrant) for women with hormone-positive (HR-positive), human epidermal growth factor receptor-2 (HER2)-negative, metastatic breast cancer that has progressed following prior endocrine (hormone) therapy. The majority of breast cancers are HR-positive. These cancers are stimulated to grow by the […]

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Tags: approval, Breast Cancer, Faslodex, fda, fulvestrant, HER2-negative, hormone-positive, Ibrance, metastatic, Metastatic Breast Cancer, News, palbociclib


February 29th, 2016

Arzerra® Approved as Maintenance Therapy for Advanced CLL

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The United States Food and Drug Administration (FDA) has approved Arzerra® (ofatumumab) as maintenance therapy for the treatment of advanced chronic lymphocytic leukemia (CLL). This product is already approved to treat patients with CLL who have not received prior therapy, or whose CLL has stopped responding to prior therapies. CLL is a type of cancer […]

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Tags: arzerra, B-cells, biologic agent, CD-20, Chronic Lymphoblastic Leukemia, chronic lymphocytic, CLL, fda, Leukemia, News, ofatumumab, PROLONG


February 11th, 2016

Vistogard® Approved for Life-Threatening Toxicities of Certain Chemotherapy Agents

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The United States Food and Drug Administration (FDA) approved Vistogard (uridine triacetate) for the treatment of life-threatening toxicities caused by the chemotherapy drugs fluorouracil or capecitabine. The approved indication is for the “emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil or Xeloda (capecitabine), or who develop certain severe […]

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Tags: Anal Cancer, Breast Cancer, capecitabine, Colon Cancer, fda, fluorouracil, Gastric Cancer, Gastrointestinal Stromal Tumors, life-threatening, Liver Cancer, News, Pancreatic Cancer