Based 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.
Niraparib 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.
The 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.
A 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 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.
The FDA has approved the PD-1 inhibitor pembrolizumab as a second-line therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma for those who have progression on a platinum chemotherapy.
The 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 />
The 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.
The FDA has approved a lighter and more convenient version of the Optune system for patients with glioblastoma multiforme.
The FDA has lifted a clinical hold placed on a phase II study exploring the CD19-targeted CAR-T cell therapy JCAR015 for adult patients with relapsed or refractory B cell acute lymphoblastic leukemia.
Treatment 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.
Napabucasin, a STAT3-targeted agent, has received an orphan drug status from the FDA for the treatment of patients with gastric or gastroesophageal junction (GEJ) cancer.
Binimetinib, a MEK inhibitor, is seeking FDA approval in the treatment of patients with advanced NRAS-mutant metastatic melanoma.
For 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.
Plasma-based genetic testing can effectively be used to determine whether a tissue biopsy is necessary for EGFR mutation analysis in patients with non-small cell lung cancer.
Regorafenib (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.
Adding 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.
Avelumab 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.
Pembrolizumab (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.
Ibrutinib (Imbruvica) continued to demonstrate impressive antitumor activity in a pooled analysis of 243 patients with deletion 17p chronic lymphocytic leukemia.
Three-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.
Patients 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 (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.
Combination therapy dabrafenib and trametinib showed positive outcomes in patients with BRAF V600E-mutant NSCLC, according to phase II trial data presented at the 2016 ASCO Annual Meeting.
Treatment 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.
Clinical trials studying a biomarker-based treatment showed substantially better results than non-personalized treatment methods in a meta-analysis that examined 13,203 patients from phase I trials.
A phase III study exploring the combination of olaparib and paclitaxel missed its primary endpoint of improvement in overall survival compared with paclitaxel and placebo for patients with advanced gastric cancer.
The FDA has granted a genetically modified version of the poliovirus known as PVS-RIPO a breakthrough therapy designation as a potential therapy for patients with advanced glioblastoma multiforme.
Extended 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.
The combination of lenvatinib (Lenvima) and everolimus (Afinitor) has been approved by the FDA as a treatment for patients with advanced renal cell carcinoma (RCC) following prior antiangiogeneic therapy.