Phase III Study for Rindopepimut in GBM Discontinued After OS Endpoint was Missed
March 8th 2016The combination of rindopepimut plus temozolomide did not improve overall survival (OS) when compared with temozolomide plus a control in patients with newly diagnosed EGFRvIII-positive glioblastoma multiforme (GBM).
Chemoradiation Drastically Improves OS for Elderly Patients With Head and Neck Cancers
February 20th 2016The 5-year overall survival (OS) in elderly patients with locally advanced head and neck cancers was drastically improved with concurrent chemoradiation versus radiation therapy alone, according to an analysis of the National Cancer Data Base.
FDA Grants Durvalumab Breakthrough Status for Bladder Cancer
February 18th 2016The FDA has granted a breakthrough therapy designation to durvalumab as a treatment for patients with PD-L1 positive inoperable or metastatic urothelial bladder cancer following progression on prior treatment with a platinum-based regimen.
FOLFOXIRI Bests FOLFOX as Bevacizumab Backbone in mCRC
February 17th 2016Marginal improvements were seen in clinical outcomes for patients with metastatic colorectal cancer (CRC) treated with FOLFOXIRI plus bevacizumab compared with FOLFOX plus bevacizumab; however, these findings were inconsistent, according to results from the phase II STEAM trial.
FDA Requests ODAC Meeting for Rociletinib Following Updated Data
February 15th 2016The FDA has scheduled an Oncologic Drugs Advisory Committee (ODAC) advisory hearing for April 12 to review the new drug application for rociletinib, a treatment for metastatic EGFR T790-mutated non-small cell lung cancer.
Clinical Review: Regorafenib in Refractory mCRC
February 11th 2016"While adverse events across both populations were broadly similar, some did occur more frequently in patients with longer exposure, an observation that is possibly related to the longer duration in this subgroup," said Axel Grothey, MD.
Second-Line Cabozantinib Boasts Rare Survival Advantage Following Progression in RCC
February 4th 2016The second interim analysis of the phase III METEOR trial has revealed a statistically significant improvement in overall survival (OS) with cabozantinib (Cometriq) versus everolimus (Afinitor) as a treatment for patients with advanced renal cell carcinoma (RCC) following progression on one prior therapy, according to a statement from the drug's developer, Exelixis.
RCC Treatment Cabozantinib Receives Priority Review From FDA
January 29th 2016Cabozantinib (Cometriq) has receieved a priority review designation from the FDA for patients with advanced renal cell carcinoma (RCC) following progression on one prior therapy, according to Exelixis, the drug's developer.
Eribulin Approved by FDA for Treatment of Advanced Liposarcoma
January 29th 2016The FDA has approved eribulin mesylate (Halaven) as a treatment for patients with advanced or unresectable liposarcoma following prior treatment with an anthracycline-based chemotherapy, based on an improvement in overall survival (OS) in a phase III study.
Updated Data Shows Sustained OS Advantage for Liposomal Irinotecan in Pancreatic Cancer
January 21st 2016Combining liposomal irinotecan (nal-IRI; MM-398; Onivyde) with 5-fluorouracil (5-FU) plus leucovorin dropped the risk of death in patients with metastatic pancreatic cancer by 25% following progression on a gemcitabine-based regimen, according to updated data from the phase III NAPOLI-1 trial.
Neoadjuvant Radiation Regimen Efficacious, Less Toxic in Patients With Rectal Cancer
January 20th 2016Preoperative treatment with short-course radiation therapy plus 3 cycles of chemotherapy boosted overall survival (OS) and generated fewer adverse events (AEs) compared to standard chemoradiation for patients with locally advanced rectal cancer.
FDA Assigns Priority Review to Lenvatinib Plus Everolimus Combo in RCC
January 19th 2016The combination of lenvatinib (Lenvima) and everolimus (Afinitor) has been given a priority review status by the FDA as a treatment for patients with metastatic renal cell carcinoma (RCC) following one prior VEGF-targeted therapy.
Ipilimumab/Chemo Combo Misses OS Endpoint in Phase II Urothelial Cancer Trial
January 10th 2016The addition of the CTLA-4 inhibitor ipilimumab to cisplatin and gemcitabine failed to significantly improve the primary endpoint of overall survival (OS) in a phase II study for patients with metastatic urothelial cancer.
Hypofractionated Radiotherapy Noninferior to Standard Radiation Therapy
January 9th 2016Hypofractionated radiotherapy and standard radiation therapy demonstrated similar toxicities and neither prevented PSA increases or disease recurrences for men with intermediate-risk prostate cancer better than the other, according to data from the phase III randomized CHHiP trial reported at the 2016 GU Cancers Symposium.
FDA Approves Non-Alcohol Formulation of Docetaxel for Multiple Cancer Types
December 29th 2015The FDA has approved a new treatment consisting of a non-alcohol formulation of docetaxel in patients with breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
New Multimodal Ovarian Cancer Screening Tactic Shows Promise
December 23rd 2015A new method of screening utilizing CA-125 and a risk assessment algorithm could drop risk of mortality from ovarian cancer in certain women, according to findings from the UK Collaborative Trial of Ovarian Cancer Screening.
European Commission Approves T-VEC for Unresectable Metastatic Melanoma
December 22nd 2015Talimogene laherparepvec (T-VEC; Imlygic) has been approved by the European Comission as a treatment for adult patients with unresectable stage IIIb, IIIc, and IVM1a melanoma that has not spread to the bone, brain, lung, or other viscera, based on the phase III OPTiM study.