The National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK) has published draft guidelines for a new renal cell carcinoma treatment. The guidelines support the use of EUSA Pharma’s (Hemel Hempstead, England) Fotivda (tivozanib) as a first-line treatment option for advanced renal cell carcinoma. NICE provides national evidence-based guidance and quality standards to practitioners in the National Health Service.
In clinical trials, patients treated with Fotivda experienced longer progression-free survival—11.9 versus 9.1 months—in the overall population compared with those taking Bayer’s Nexavar (sorafenib). The drug also reduced side effects: 14% of patients on Fotivda compared with 43% of patients on Nexavar needed a dose reduction due to adverse events, noted EUSA Pharma. The company said it plans to pursue FDA approval.
In other news, AstraZeneca said it expects an FDA decision about its drug ZS-9, a candidate to treat hyperkalemia, during the first half of 2018.
The company noted that problems uncovered at a manufacturing facility in Texas that resulted in the FDA’s suspending the drug’s approval process have been ameliorated.
Third, Bizjournals.com reported that a drug that may help the immune system’s chances of slowing progression of several different cancers has placed Nektar Therapeutics in the path of a potential $3.6 billion deal with Bristol-Myers Squibb (BMS) (New York, NY). Nektar’s value to BMS is the potential for its investigational drug NKTR-214 to be used in combination with other BMS drugs to stimulate the immune system and fight renal and other cancers. NKTR-214 is believed to stimulate the immune system into producing a protein called PD-1.
Nektar (San Francisco, CA) is being eyed for a trial with Opdivo and also a three-drug combination trial with Opdivo and Yervoy, which bind to PD-1. Early results from a collaboration the companies started in fall 2016 showed that NKTR-214 and Opdivo together could generate a response in more than half of patients, including those with cancers in which PD-1 is not expressed.
Studies in renal cell carcinoma and melanoma are expected to begin in mid-2018, reports ClinicalLeader.com.
And Danish in vitro diagnostics firm BioPorto announced in February 2018 a deal with Roche for the global distribution of a neutrophil gelatinase-associated lipocalin (NGAL) test for use on the Cobas c 501 and Cobas c 502 clinical analyzers, according to GenomeWeb.
NGAL is a diagnostic biomarker that alerts clinicians to acute kidney injury within a few hours. BioPorto’s NGAL test has the European CE mark of approval.
The company is conducting research to generate data ahead of potential approval by the US Food and Drug Administration, potentially later this year.
