CD38-Specific Monoclonal Antibody Demonstrates Encouraging Efficacy in Myeloma
June 9th 2014SAR650984 demonstrated encouraging efficacy as a monotherapy and in combination with dexamethasone and lenalidomide without reaching a maximum tolerated dose in patients with heavily pretreated multiple myeloma.
Ibrutinib Dramatically Increases PFS, OS in Phase III CLL Study
June 1st 2014Treatment with single-agent ibrutinib (Imbruvica) dramatically increased progression-free survival (PFS) by nearly 80% and significantly extended overall survival (OS) by 57% compared with ofatumumab in patients with relapsed or refractory chronic lymphocytic leukemia (CLL).
Panitumumab Gains FDA Approval for KRAS Wild-Type mCRC
May 24th 2014The FDA has approved panitumumab (Vectibix) in combination with chemotherapy as a frontline treatment for patients with <em>KRAS</em> wild-type metastatic colorectal cancer (mCRC), based on findings from two phase III clinical trials.
FDA Grants Breakthrough Therapy Designation for CO-1686 for EGFR T790M-Positive NSCLC
May 21st 2014The EGFR inhibitor CO-1686 has received a breakthrough therapy designation from the FDA for its potential as a treatment for patients with metastatic T790M mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of EGFR-targeted therapy.
Vemurafenib/ Cobimetinib Combination Demonstrates Efficacy in Melanoma
May 9th 2014The combination of vemurafenib with the investigational MEK inhibitor cobimetinib demonstrated a 13.7-month median PFS and an ORR of 87% in treatment-naïve patients with BRAFV600 mutation-positive metastatic melanoma.
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.
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.
Findings From Next-Generation Sequencing Offer Promise for New Breast Cancer Therapies
March 24th 2014The most promising novel therapeutics in development for patients with breast cancer focus primarily on targeting activating mutations in combinations that are based on findings from next-generation sequencing.
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.