News

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.

The addition of cetuximab (Erbitux) to standard FOLFOX-4 chemotherapy in the first-line treatment of patients with RAS wild-type metastatic colorectal cancer (mCRC) significantly improved survival outcomes in a phase III clinical trial that builds upon the regimen's efficacy, particularly for Asian patients, and may help pave the way for its approval in China.

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.

A study of nivolumab (Opdivo) in patients with squamous cell carcinoma of the anal canal (SCCA), which recently presented findings at the 2016 World Congress on Gastrointestinal (GI) Cancer, is the first prospective trial to examine immunotherapy agents in the treatment of SCCA.

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.

While PD-L1 has been perceived as an important biomarker in the realm of lung cancer, Keith Kerr, BSc, MB, ChB, FRCPath, FRCPE, says it still has a long way to go.

The FDA has released 2 draft guidances regarding the use of next-generation sequencing-based tests.

Geoffrey R. Oxnard, MD, specializes in researching molecular mutations in non-small cell lung cancer (NSCLC) with a particular emphasis on prognostic and predictive biomarkers. Oxnard spoke with Targeted Oncology about the potential for BRAF-targeting therapies in NSCLC.

Given the lack of treatment options for patients with recurrent/metastatic head and neck squamous cell carcinoma, the need for novel therapies is dire.

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.

A recent study uncovered BRCA1 and BRCA2 mutations as possible risk markers for colorectal cancer.

Preliminary data shows an anthracycline/taxane-based chemotherapy regimen (TaxAC) could be superior to docetaxal plus cyclophosphamide in patients with breast cancer.

Screening for microsatellite instability in patients with colorectal cancer tumors is a significant step in determining which patients will benefit from immunotherapy, specifically pembrolizumab.

Multigene panel testing may uncover new risks in breast cancer and ovarian cancer.

Many patients with metastatic colorectal cancer (CRC) will ultimately progress on standard first- and second-line therapy while maintaining a good performance status, placing importance on the optimal use of third-line treatments.

Therapeutic options have been severely limited for patients with locally advanced or unresectable basal cell carcinoma.

Hendrik-Tobias Arkenau, MD, PhD, discusses the phase I JAVELIN trial as well as the future of treatments and immunotherapies in the treatment paradigm of gastrointestinal cancers.

A phase Ib trial shows strong potential for the use of utomilumab in combination with pembrolizumab (Keytruda) for patients with advanced solid tumors, according to Anthony Tolcher, MD.

TNFSF11, also known as RANKL, shows potential as a genetic pathway in the prevention of breast cancer for women carrying BRCA1 mutations. Early study findings, published in Nature Medicine, show that a drug currently used in the treatment of osteoporosis, denosumab (Xgeva)-an inhibitor of RANKL-could also be used for the prevention and delay of tumor growth for BRCA1-mutation carriers.

The combination of nivolumab (Opdivo) and ipilimumab showed efficacy in a recent study looking at patients with colorectal cancer (CRC), according to Michael Overman, MD.

Colorectal cancer (CRC) patients that express amplified HER2 genes may be resistant to standard-of care therapy, says Kanwal Raghav, MD.

Current progress on targeted and immunotherapy agents for the treatment of sarcomas from the 2016 ASCO Annual Meeting were discussed with Jonathan C. Trent, MD, PhD.

The combination of ipilimumab (Yervoy) and nivolumab (Opdivo) continues to show promise, with recent data demonstrating a 26% improvement in overall survival (OS) with the 2 drugs compared with ipilimumab alone for patients with advanced melanoma.

The National Institute for Health and Care Excellence (NICE) has approved the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for patients with metastatic melanoma, which allows the combination to be used within the National Health Service (NHS).

Choosing between immunotherapy and targeted therapy in the frontline setting for patients with BRAF-mutated melanoma does not have to be a guessing game, according to Keith T. Flaherty, MD.

The United States Preventative Services Task Force (USPSTF) has updated its 2008 recommendation for colorectal cancer (CRC) screening to include 7 CRC screening tests for average-risk, asymptomatic adults between the ages of 50 and 75 to reduce the risk of CRC mortality.

Although nivolumab (Opdivo) and ipilimumab (Yervoy) are approved in combination for the first-line treatment of patients with metastatic melanoma, regardless of BRAF mutation status, the checkpoint blockade has not automatically become the standard of care in this setting.

While the ALSYMPCA trial led to the FDA approval of radium-223 dichloride (Xofigo), the phase III study left several questions to be answered regarding its use in metastatic castration-resistant prostate cancer (mCRPC), says Luke Nordquist, MD.

Patients with nonfunctioning neuroendocrine tumors of gastrointestinal or lung origin continued to live longer when treated with the mammalian target of rapamycin (mTOR) inhibitor everolimus than with placebo, ongoing follow-up in a randomized trial showed.