Niraparib is a Breakthrough for Patients With Ovarian Cancer, Expert Says
October 8th 2016Maintenance therapy with the PARP1/2 inhibitor niraparib reduced the risk of progression or death by 73% compared with placebo for patients with germline <em>BRCA</em>-positive platinum-sensitive, recurrent ovarian cancer, according to findings from the phase III NOVA trial.
Combination of Encorafenib and Binimetinib Improves PFS in Melanoma
September 26th 2016Part 1 of the phase III COLUMBUS trial has shown positive results for the combination of the BRAF inhibitor encorafenib (LGX818) and the MEK inhibitor binimetinib (MEK162) for patients with <em>BRAF</em>-mutant melanoma.
BeGEV Regimen Effective Induction Therapy for Hodgkin Lymphoma
September 22nd 2016According to findings of a recent study, Induction therapy with the combination of bendamustine, gemcitabine, and vinorelbine (BeGEV) effectively induced complete remissions (CRs) for nearly three-fourths of patients with relapsed or refractory Hodgkin lymphoma prior to autologous stem-cell transplantation (ASCT)
NDA for Neratinib in HER2-Positive Breast Cancer Accepted by FDA
September 21st 2016A new drug application (NDA) for neratinib as an extended adjuvant therapy for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab (Herceptin) has been accepted by the FDA
CHMP Recommends Conditional Approval for Ixazomib Combo in Myeloma
September 19th 2016Based on findings from the phase III TOURMALINE-MM1 study, the Committee for Medicinal Products for Human Use (CHMP) has recommended a conditional approval for ixazomib (Ninlaro) in combination with lenalidomide and dexamethasone as a treatment for patients with multiple myeloma who have received at least 1 prior therapy.
FDA Gives Niraparib Fast Track Designation for Ovarian Cancer
September 19th 2016Niraparib has been granted a fast track designation by the FDA as a treatment for women with recurrent platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer, the company developing the PARP inhibitor, Tesaro, has announced.
Ofatumumab Combination Approved by FDA for Relapsed CLL
August 31st 2016The FDA has approved ofatumumab (Arzerra) in combination with fludarabine and cyclophosphamide as a treatment for patients with relapsed chronic lymphocytic leukemia (CLL). The approval was based on an improvement in progression-free survival (PFS) in the phase III COMPLEMENT-2 study.
Brigatinib Submitted to FDA to Treat ALK-Positive NSCLC
August 30th 2016A new drug application (NDA) has been submitted for brigatinib (AP26113) as a potential treatment for patients with advanced ALK-positive non–small cell lung cancer (NSCLC) following resistance or intolerance to crizotinib (Xalkori).
Pfizer to Acquire Medivation, Developer of Enzalutamide
August 29th 2016Pfizer has announced plans to acquire the biopharmaceutical company Medivation, which is the developer of the androgen receptor inhibitor enzalutamide (Xtandi). Under the terms of the agreement, Pfizer will pay $81.50 per share in cash for Medivation, totaling approximately $14 billion. Both companies agreed to the transaction, which is expected to complete later this year.
Breakthrough Designation Allotted to Ribociclib for Breast Cancer Treatment
August 3rd 2016The CDK4/6 inhibitor ribociclib (LEE011) has received a breakthrough therapy designation from the FDA for its potential as a frontline therapy when given in combination with letrozole for patients with hormone-receptor (HR)-positive, HER2-negative advanced breast cancer.<br />
CHMP Recommends Liposomal Irinotecan in Pancreatic Cancer Following Positive Findings
July 26th 2016The Committee for Medicinal Products for Human Use has recommended the approval of pegylated liposomal irinotecan in combination with fluorouracil and leucovorin for patients with metastatic pancreatic adenocarcinoma following progression on a gemcitabine-based therapy.
Novel FGFR Inhibitor Shows Promise in Cholangiocarcinoma
July 8th 2016Treatment with ARQ-087 demonstrated promising signs of clinical activity with a manageable safety profile for patients with FGFR2 fusion-positive advanced and/or metastatic intrahepatic cholangiocarcinoma, according to findings from an ongoing phase I/II study presented at the 2016 World Congress on Gastrointestinal Cancer.
Biomarkers, Subtyping Help Guide Neoadjuvant/Adjuvant Breast Cancer Treatment Decisions
July 8th 2016For patients with early-stage invasive breast cancer and known estrogen receptor, progesterone receptor, and HER2 status, ASCO's February 2016 release of their evidence-based recommendations helped define appropriate use of biomarker assay results in guiding adjuvant treatment decisions.
Regorafenib Seeking FDA Approval in HCC Following Findings of OS Boost
July 6th 2016Regorafenib (Stivarga) as a second-line therapy for patients with unresectable hepatocellular carcinoma (HCC) who have progressed on sorafenib (Nexavar), showed an improved overall survival (OS) rate of 2.8 months over placebo. Findings from the phase III RESORCE study will be submitted to the FDA and European Medicines Agency (EMA) for potential approval, according to a statement from the developer of regorafenib, Bayer Pharmaceuticals.
Utomilumab/Pembrolizumab Combo Shows Responses in Different Solid Tumors
June 15th 2016Adding utomilumab (PF-05082566), a 4-1BB agonist, to pembrolizumab (Keytruda), a PD-1 inhibitor, was shown to be a safe and effective combination therapy for patients with different types of advanced solid tumors, according to findings from a phase Ib study presented at the 2016 ASCO Annual Meeting.
Findings Support Use of Avelumab in Metastatic Merkel Cell Carcinoma
June 15th 2016Avelumab showed early positive survival data and lasting responses for patients with pretreated advanced or metastatic Merkel cell carcinoma, according to findings from the phase II JAVELIN Merkel 200 trial presented at the 2016 ASCO Annual Meeting.
Studies Show Durable Activity of Pembrolizumab in Head and Neck Cancer
June 15th 2016Pembrolizumab (Keytruda), when studied in 2 clinical trials for the treatment of patients with pretreated recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), showed an objective response rate (ORR) of 18%, according to findings presented at the 2016 ASCO Annual Meeting.
3-Year Follow-Up Data for Dabrafenib/Trametinib Confirm Results of Combo in Melanoma
June 11th 2016Three-year follow-up data from the phase III COMBI-d study was presented at the 2016 ASCO Annual Meeting, revealing impressive overall survival (OS) and progression-free survival (PFS) data for the dabrafenib (Tafinlar) and trametinib (Mekinist) combination therapy for patients with BRAF-mutant metastatic melanoma.
Nivolumab Monotherapy Shows Encouraging Efficacy in Glioblastoma Patients
June 11th 2016Patients with recurrent glioblastoma mutliforme reacted well to nivolumab (Opdivo) monotherapy, according to findings from the CheckMate-143 trial that were presented at the 2016 ASCO Annual Meeting. The single agent showed a manageable safety profile and promising efficacy signs during the course of the study.
Nivolumab Monotherapy Improves Responses in Head and Neck Squamous Cell Carcinoma
June 9th 2016Nivolumab (Opdivo) monotherapy showed improved overall survival (OS) and objective response rates for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) compared with the investigator's choice of alternative therapy, according to data presented at the 2016 ASCO Annual Meeting.
Rovalpituzumab Tesirine Single-Agent Activity and Safety Profile Prove Positive in SCLC
June 7th 2016Treatment with the delta-like protein 3 (DLL3)-targeted antibody-drug conjugate rovalpituzumab tesirine demonstrated single-agent activity and a manageable safety profile for patients with recurrent/refractory SCLC.