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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.
Durvalumab/Tremelimumab Shows Efficacy in NSCLC
February 16th 2016Patients with advanced non-small cell lung cancer receiving the combination checkpoint blockade with the PD-L1 inhibitor durvalumab and the anti-CTLA-4 agent tremelimumab had a response rate of 23%, according to phase Ib data from Study 006.
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.
Immunotherapies and the Challenge They Present in Melanoma
February 13th 2016With the field of immunotherapy growing at a rapid rate, and its increasing incorporation in the armamentarium of treatments in melanoma, Jeffrey S. Weber, MD, PhD, discusses where the field is going and how oncologists can be using the therapies.
MRI-Guided, Convection-Enhanced Therapy on Horizon for High-Grade Gliomas
February 11th 2016A new treatment delivery method is being explored that combines real-time imaging with convection-enhanced delivery of chemotherapy for patients with high-grade gliomas, according to the lead investigator of early phase research exploring the approach, Nicholas A. Butowski, MD.
T-Cell Therapy Granted FDA Breakthrough Designation in Sarcoma
February 11th 2016The FDA has granted an affinity enhanced T-cell therapy breakthrough therapy designation for patients with inoperable or metastatic pretreated synovial sarcoma who harbor HLA-A*201, HLA-A*205, or HLA-A*206 alleles and whose tumors express the NY-ESO-1 tumor antigen
Classifying and Understanding Pediatric Medulloblastoma
February 9th 2016The understanding that medulloblastoma is comprised of 4 distinct molecular subtypes of disease, each representing a unique opportunity for new drug development, has set the groundwork for a wave of advances in the treatment of pediatric brain cancer, according to Matthias A. Karajannis, MD.
Novel Therapies Set to Revolutionize Glioma Treatment
February 9th 2016Targeted Oncology spoke with Andrew S. Chi, MD, PhD, head of Neuro-Oncology at NYU Langone's Laura and Isaac Perlmutter Cancer Center, on recent developments in the treatment paradigm for patients with brain cancer, including his recent study into mutant IDH1 gliomas and the role of the NAD metabolite.
FDA Assigns Sacituzumab Govitecan Breakthrough Designation for TNBC
February 9th 2016The FDA has granted sacituzumab govitecan (IMMU-132) breakthrough therapy designation for the treatment of patients with triple-negative breast cancer (TNBC) following at least 2 treatments for metastatic disease, according to Immunomedics, the manufacturer of the investigational antibody-drug conjugate.
Adjuvant Chemotherapy Postcystectomy Elongates Survival in Bladder Cancer
February 6th 2016Adjuvant chemotherapy was associated with improved overall survival (OS) compared with observation postcystectomy in patients with pathologic T3/4 and/or pathologic node-positive bladder cancer, according to a retrospective analysis published in the Journal of Clinical Oncology.
Risk Should Dictate the Aggressiveness of Prostate Cancer Treatment
February 5th 2016Matthew Cooperberg, MD genitourinary cancer specialist, University of California San Francisco (UCSF), discusses the varying management techniques for both low- and high-risk prostate cancers, including radiation therapy, surgery, hormonal therapy, and active surveillance.
Complete Response Letter Issued by FDA for Bladder Cancer Immunotherapy MCNA
February 5th 2016The FDA issued a complete response letter to Telesta Therapeutics informing the company that its biologics license application (BLA) for MCNA in bladder cancer would not be approved and that an additional phase III clinical trial was needed to adequately evaluate the immunotherapy.
Study Reveals HER2 Breast Cancer Subtype Beneficial for Treatment Individualization
February 4th 2016Approximately 33% of patients with HER2-positive breast cancer have also been found to have a luminal subtype resistant to chemotherapy and trastuzumab. Peter Beitsch, MD, discusses the triplet neoadjuvant regimen of pertuzumab, trastuzumab, and chemotherapy, and its effect on the subtype in the Neoadjuvant Breast Registry Symphony Trial (NBRST) study.
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.
Radium-223 Retreatment Deemed Safe in Bone-Metastatic Prostate Cancer
February 3rd 2016Retreatment with radium-223 dichloride (Xofigo) after initial therapy and progression was deemed safe in patients with bone-metastatic castration-resistant prostate cancer (CRPC), according to a recent prospective, open-label phase I/II trial.
Cells Gang Up to Form Breast Cancer Metastases, Study Shows
February 2nd 2016A team of researchers at both the Fred Hutchinson Cancer Research Center and Johns Hopkins Medical Institute have discovered that cancer metastization occurs through the migration of malignant cells in groups, rather than single cells, in a recent study.
Evidence Connects Polymorphisms of GSTM1 and GSTT1 to Increased RCC Risk
January 30th 2016A recent meta analysis of several literature sources reveals evidence linking polymorphisms of both the GSTM1 and GSTT1 enzymes, which are involved in kidney detoxification of carcinogens to the risk of developing of renal cell carcinoma (RCC).
Venetoclax Receives FDA Breakthrough Designation in AML
January 29th 2016The FDA has granted breakthrough therapy designation to Venetoclax combined with hypomethylating agents in patients with treatment-naive acute myeloid leukemia (AML) who are not eligible for standard high-dose induction treatment, according to AbbVie, which is codeveloping the BCL-2 inhibitor with Genentech.
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.