Cancer Drug Limbo

Kidney cancer metastasis drug dovitinib beats sunitinib in mice

(RxWiki News) Due to the high standards required by the clinical testing process for pharmaceuticals, cancer drugs can linger in limbo for several years before securing approval.

Trials with several different types of cancers may be tested until one sticks.

Recent testing in mice using human kidney cancer samples showed that dovitinib was more effective than sunitinib, the current standard for kidney cancer therapy.

A phase III clinical trial will undergo the same comparison later this year, providing more evidence for the drug's effectiveness.

"Ask your oncologist about clinical trials available to you."

Research from The University of Texas Southwest Medical Center shows that dovitinib seems like an ideal cancer drug. It's available as a pill; it targets a smorgasbord of genes involved in many cancers, and it has few serious side effects. 

Although the bar has been raised for cancer drugs, dovitinib will finally begin the third phase of clinical testing this year. 

The current nature of pharmaceutical development in cancer is that a company has to prove its drug is significantly better than the standard treatment a requirement that when met rewards the company that finished the clinical trial process.

Since extensive testing and clinical trials usually, for ethical reasons, begin with patients who have cancers that haven't responded to other therapies, it's a considerably more difficult performance environment.

Results presented last year at the annual meeting of the American Society for Clinical Oncology showed that out of 51 patients treated with dovitinib an average of 90 days, the length of time the cancer stopped growing was six months, and overall survival was extended to 16 months.

A previous drug trial performed in 2011 tested dovitinib in treating breast cancer, but was discontinued due to lack of effective results. Other trials currently under way for the drug focus on liver and adrenal gland. A general trial for solid tumors is also being conducted in Japan.

So far, side effects documented in the dovitinib clinical trials have shown frequent fatigue, nausea and diarrhea, as well as a few cases of inflammation, immune system suppression and increased blood pressure.

Dovitinib targets four of the most common molecular pathways involved in cancer development, including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF) and fibroblast growth factor receptor (FGFR).

The paper concerning laboratory studies on dovitinib in mice was published in the journal Science Translational Medicine on June 6, 2012. 

Several abstracts from presentations on dovitinib have been published on the American Society for Clinical Oncology's website, as well as in the Journal of Clinical Oncology.

Researchers involved in the study disclosed financial relationships with Pfizer, AVEO, GlaxoSmithKline, Novartis, Bayer Schering Pharma, Roche, US Oncology, Amgen, Bayer, Boehringer Ingelheim, Celgene, Clinical Care Options, Cougar Biotechnology, Dendreon, Eisai, Genentech, Johnson&Johnson, Takeda, Veridex, Algeta, ArQule, Tokai and Wilex.

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Review Date: 
June 7, 2012