Extended RESONATE Data Illuminates Ibrutinib's Benefits in High-Risk CLL
May 16th 2016Extended follow-up data continue to demonstrate the efficacy and tolerability of ibrutinib in previously treated patients with chronic lymphocytic leukemia, including those with high-risk gene mutations and prognostic features.
CHMP Recommends Approval for Bevacizumab/Erlotinib Regimen for NSCLC
May 6th 2016The Committee for Medicinal Products for Human Use has recommended the first-line approval of bevacizumab (Avastin) in combination with erlotinib (Tarceva) for patients with advanced or metastatic EGFR-mutant non-small cell lung cancer.
Novel BTK, PI3K Inhibitors on Horizon for Relapsed CLL
April 30th 2016With nearly a dozen new PI3K and BTK inhibitors currently in development for patients with relapsed chronic lymphocytic leukemia it is challenging to know which therapies are truly "next-generation" agents and which are "me too" products.
Nivolumab Granted FDA Breakthrough Designation for Head and Neck Cancer
April 25th 2016Nivolumab (Opdivo) has been granted a breakthrough therapy by the FDA as a treatment for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) following a platinum-based therapy.
Palbociclib Boosts PFS in Phase III Breast Cancer Study
April 22nd 2016The phase III PALOMA-2 trial has shown a significant improvement in progression-free survival (PFS) for the frontline combination of palbociclib (Ibrance) and letrozole compared letrozole alone for patients with ER-positive, HER2-negative advanced or metastatic breast cancer.
Nivolumab Produces Robust 5-Year OS Rates in Melanoma
April 18th 2016Single-agent nivolumab (Opdivo) demonstrated a robust 5-year overall survival (OS) rate of 34% for heavily pretreated patients with metastatic melanoma who had not received prior ipilimumab (Yervoy), according to long-term findings from a single-arm phase I study.
Pembrolizumab Granted FDA Priority Review for HNSCC
April 14th 2016The FDA has granted a priority review designation to pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) following a platinum-based chemotherapy, according to a statement from Merck, the company developing the PD-1 inhibitor.
Telotristat Etiprate Application for Carcinoid Syndrome Submitted to FDA
March 31st 2016A new drug application (NDA) has been submitted to the FDA for telotristat etiprate as a treatment for carcinoid syndrome in patients with metastatic neuroendocrine tumors (NETs), according to a statement from the drug's developer, Lexicon Pharmaceuticals.
FDA Approves Defibrotide in Hepatic VOD Post-Stem Cell Transplantation
March 31st 2016The FDA has approved defibrotide sodium (Defitelio) as a treatment for severe hepatic veno-occlusive disease (VOD) with associated kidney or lung abnormalities following hematopoietic stem cell transplantation (HSCT), based on data from the collection of 3 studies.
Liposomal Irinotecan Combo Added to NCCN Guideline for Pancreatic Cancer in Second-Line
March 26th 2016Liposomal irinotecan (irinotecan liposome injection; Onivyde), fluorouracil (5-FU), and leucovorin in combination has been added to the 2016 NCCN Clinical Practice Guidelines in Oncology as a second-line treatment for patients with gemcitabine-refractory metastatic pancreatic cancer.
Abiraterone Acetate Plus Prednisone Demonstrates OS Benefit in Prostate Cancer
March 18th 2016An abiraterone acetate (Zytiga) plus prednisone combination showcased an 11.8-month improvement in overall survival (OS) when compared with prednisone and placebo in less advanced, chemotherapy-naive metastatic castration-resistant prostate cancer.
Liver-Directed Therapy Shows Promise in Select Patients With mCRC
March 14th 2016The addition of Yttrium-90 (Y-90) resin microspheres (SIR-Spheres) to standard frontline FOLFOX-based chemotherapy with or without bevacizumab significantly improved liver-specific progression-free survival (PFS) for patients with liver metastatic colorectal cancer (CRC), according to findings from the phase III SIRFLOX study published in the Journal of Clinical Oncology.