Items Tagged ‘News’

March 11, 2019

Non-Chemotherapy Combo Approved for Treatment-Naïve CLL/SLL Patients

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The U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) in combination with Gazyva (obinutuzumab) for treatments of patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). 1 The FDA approval was based on results from the Phase 3 iLLUMINATE clinical trial which compared Gazyva administered with either Imbruvica or chlorambucil in 212 adult patients. […]

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Tags: Leukemia, News


March 8, 2019

FDA Approves Lonsurf® for Treatment of Advanced Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

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The United States Food and Drug Administration (FDA) has approved Lonsurf® (trifluridine/tipiracil)) as a treatment for adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. About Lonsurf Lonsurf consists of […]

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Tags: Gastric Cancer, News


March 4, 2019

FDA Approves Keytruda for Adjuvant Treatment of Melanoma

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On February 15, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck) for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection. Approval was based on EORTC1325/KEYNOTE‑054 (NCT02362594), a randomized, double-blind, placebo-controlled, trial in 1019 patients with completely resected, stage IIIA (>1 mm lymph node metastasis), IIIB or IIIC […]

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Tags: Melanoma, News


February 28, 2019

Lynparza significantly delayed disease progression as 1st-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer

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Results from the trial showed a significant and clinically-meaningful improvement in progression-free survival (PFS) with Lynparza (olaparib) for the treatment of BRCA-mutated pancreatic cancer. POLO is a randomised, double-blinded, placebo-controlled trial exploring the efficacy of Lynparza tablets as 1st-line maintenance monotherapy in patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose […]

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Tags: News, Pancreatic Cancer


February 25, 2019

Isatuximab – Promising for Treatment of Myeloma

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A phase 3 comparative clinical trial evaluating Isatuximab has met the primary endpoint of delaying cancer progression in patients with relapsed/refractory multiple myeloma. Multiple myeloma is the second most common hematologic malignancy, with more than 138,000 new cases worldwide each year. Multiple myeloma remains incurable in the vast majority of patients, resulting in significant disease […]

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Tags: Melanoma, News


February 21, 2019

Keytruda Approved for Treatment of Stage III Melanoma

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The U.S. Food and Drug Administration (FDA) has approved Keytruda for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete surgical resection. Adjuvant Therapy in Melanoma Melanoma is separated into five staging categories (stages 0-4).  Stage 3 melanoma is a cancer that has spread to the regional lymph nodes but […]

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Tags: Melanoma, News


February 18, 2019

FDA Approves Nivolumab and Ipilimumab Combination for Advanced Kidney Cancer

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The Food and Drug Administration (FDA) approved the immunotherapy drugs Opdivo and Yervoy in combination as an initial, or first-line, treatment for patients with advanced kidney cancer whose disease has an intermediate or poor prognosis. This is the first immunotherapy regimen to be approved by FDA for the initial treatment of patients with kidney cancer. […]

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Tags: News, Renal Cancer


February 18, 2019

Keytruda Plus Inlyta Improves Survival Compared ot Sutent for Treatment of Advanced Kidney Cancer

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Results from the randomized, phase III KEYNOTE-426 clinical trial show that first-line therapy with a combination of the PD-1 targeted immunotherapy Keytruda (pembrolizumab) and the VEGF-targeted tyrosine kinase inhibitor Inlyta (axitinib) improved overall survival and delayed cancer progression-free for patients with clear-cell metastatic renal cell carcinoma, compared to the current standard of care, Sutent (sunitinib). […]

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Tags: News, Renal Cancer


February 13, 2019

Personalized Vaccine to be Tested in Patients with Kidney Cancer

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By pairing a novel personalized cancer vaccine with a more established immunotherapy drug that is administered to patients in an innovative fashion, scientists at Dana-Farber Cancer Institute are testing a first-of-its-kind strategy aimed at improving outcomes for kidney cancer patients who are at high risk of recurrence following surgery. This two-pronged approach to mobilizing a […]

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Tags: News, Renal Cancer


February 11, 2019

Adjuvant Taxotere Doesn’t Improve Outcomes in Early Stage High Risk Prostate Cancer

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Patients with high-risk, non-metastatic prostate cancer saw no survival advantage and no delay in metastases with the addition of adjuvant docetaxel to androgen deprivation therapy (ADT), according to the results of a pivotal clinical randomized trial published in JAMA Oncology. The clinical trial included 254 men with androgen-dependent, non-metastatic prostate cancer with rising PSA levels. […]

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Tags: News, Prostate Cancer


January 29, 2019

Personalized Vaccine to be Tested in Patients with Kidney Cancer

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By pairing a novel personalized cancer vaccine with a more established immunotherapy drug that is administered to patients in an innovative fashion, scientists at Dana-Farber Cancer Institute are testing a first-of-its-kind strategy aimed at improving outcomes for kidney cancer patients who are at high risk of recurrence following surgery. This two-pronged approach to mobilizing a […]

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Tags: News, Renal Cancer


January 25, 2019

TVEC-Genetically Modified Virus Injection into Tumor – A Valid Treatment for Metastatic Melanoma

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Results published in the Journal of the American College of Surgeons show sustained effectiveness of disease response and favorable side effect profile. CHICAGO (January 25, 2019): Injection of a genetically modified virus that induces the body’s own immune cells to attack metastatic melanoma effectively treated almost 40 percent of patients with tumors that could not […]

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Tags: Melanoma, News


December 31, 2018

Targeted Radiation with 177Lu-PSMA-617 is Promising Treatment for Advanced Prostate Cancer

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177Lu-PSMA-617 is a member of a new class of drugs that deliver radiation directly to tumor cells to obliterate them. These targeted radiation treatments consist of a radioactive isotope attached to a molecule that specifically targets tumor cells. In this case, the radioactive isotope is 177-lutetium (177Lu), an unstable form of the element lutetium, which […]

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Tags: News, Prostate Cancer


December 28, 2018

Immunotherapy Offers New Hope in Triple Negative Breast Cancer

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Results from the Impassion 130 clinical trial published in the New England Journal of Medicine have demonstrated that immunotherapy can improve survival in breast cancer, especially in anti-programmed cell death ligand 1 (PD-1+) patients.  The results were seen with the PD-L1 drug Tecentriq used in combination with chemotherapy for the treatment of triple negative breast cancer. […]

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Tags: Breast Cancer, News


December 21, 2018

Herceptin Biosimilar Herzuma Approved for Certain Breast Cancer Indications

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The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer. Herzuma is the second oncology biosimilar approval in the United States in the past month. Specifically, Herzuma is approved to treat: Adjuvant breast cancer of HER2 overexpressing node positive or node negative (ER/PR negative […]

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Tags: Breast Cancer, News