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Ramucirumab Approved by FDA for Gastric and GEJ Adenocarcinoma
April 22nd 2014The FDA has approved ramucirumab as a treatment for patients with unresectable gastric cancer or GEJ adenocarcinoma following fluoropyrimidine- or platinum-containing therapy, based on a significant extension in overall survival (OS).
First-Line Ofatumumab Approved by FDA for Chemotherapy-Ineligible Patients With CLL
April 18th 2014The FDA has approved ofatumumab (Azerra) plus chlorambucil for previously untreated patients with chronic lymphocytic leukemia (CLL) who are considered inappropriate for treatment with fludarabine therapy.
Neratinib Shows Promise for HER2-Positive Breast Cancer in I-SPY 2 Trial
April 10th 2014The adaptive I-SPY 2 trial has found that a neoadjuvant regimen of neratinib and standard chemotherapy is beneficial for high-risk patients with hormone receptor (HR)-negative, HER2-positive stage II/III breast cancer.
MAGE-A3 Immunotherapeutic Fails to Improve DFS in NSCLC
April 3rd 2014The large phase III MAGRIT study investigating the MAGE-A3-specific vaccine GSK1572932A for patients with non-small cell lung cancer (NSCLC) will be completely halted following an interim analysis that demonstrated a lack of benefit.
FDA Panel Endorses Whole-Blood CRC Screening Tool by Narrow Margin
March 28th 2014The blood-based colorectal cancer (CRC) screening test Epi proColon passed the scrutiny of the FDA’s Molecular and Clinical Genetics advisory panel in a close 5-4 vote with 1 abstention in support of the claim that the test’s benefits outweigh its risks.
DFS Not Extended With MAGE-A3-Specific Immunotherapeutic in NSCLC
March 21st 2014The MAGE-A3-specific immunotherapeutic GSK1572932A failed to significantly extend disease-free survival (DFS) in patients with resected nonmetastatic non-small cell lung cancer (NSCLC) who tested negative for a specific gene expression signature.
mTOR Mutations in Exceptional Responder Suggest Sensitivity to Everolimus in Bladder Cancer
March 14th 2014An exceptional responder with advanced urothelial carcinoma experienced a complete radiologic response lasting 13.8 months following treatment with the combination of everolimus (Afinitor) and pazopanib (Votrient).
Earlier Prophylactic Surgery More Beneficial for BRCA1 Carriers
February 26th 2014According to a new study, physicians now have a clearer understanding of the optimum age for prophylactic oophorectomy in patients with BRCA mutations who want to reduce their risk of ovarian, fallopian tube, and breast cancer.
Ramucirumab/Docetaxel Combination Demonstrates Survival Benefit in NSCLC
February 20th 2014The second-line administration of ramucirumab in combination with docetaxel demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared with placebo plus docetaxel in patients with non-small cell lung cancer (NSCLC). The announcement was made Feb. 19 by Eli Lilly and Company, the company developing the agent.
MK-3475 to be Evaluated Across Wide Range of Cancers
February 7th 2014Merck announced the signing of three separate clinical collaboration agreements to evaluate the potential of MK-3475 across multiple tumor types. The agreements were signed through subsidiaries with Amgen Inc., Incyte Corporation, and Pfizer Inc.
FDA Grants Breakthrough Therapy Designation for Eltrombopag for SAA
February 5th 2014The FDA has granted a Breakthrough Therapy designation for the small molecule thrombopoietin receptor (TPOR) agonist eltrombopag (Promacta) for the treatment of cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy.