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- Patients Rights and Responsibilities
Top Stories (pdf format)
- FDA approves GlaxoSmithKline's Votrient for advanced renal cell cancer
- Extavia Approved for Multiple Sclerosis
- ACS announces the Ribavirin Blister Pack Program
- Simponi receives FDA approval for treatment of arthritis
- Afinitor approved and available at ACS Pharmacy
Other News
Data from mid-stage study show Novartis'
Afinitor may reduce pancreatic tumour growth
Novartis said Wednesday its cancer drug Afinitor (everolimus), as monotherapy and in combination with Sandostatin LAR (octreotide), may have the potential to control tumour growth in patients with advanced pancreatic neuroendocrine tumours (NET). A final analysis of data from the Phase II trial showed that 84 percent of patients with the disease who took the drug combination experienced tumour shrinkage.
The RADIANT-1 study involved 160 patients with advanced pancreatic NET resistant to treatment with cytotoxic chemotherapy. Results showed that the group of 45 patients who received Afinitor once daily in combination with Sandostatin LAR had no progression in their disease for a median of 16.7 months. In the Afinitor monotherapy arm of 115 patients, data showed no disease progression for 9.7 months, and nearly 60 percent of subjects experienced a decrease in tumour size. Novartis noted that the study was not designed to compare the two treatment groups.
The drugmaker stated that data from the study will be presented at the 11th World Congress on Gastrointestinal Cancer. In addition, Novartis said it has completed enrolment for the Phase III RADIANT-3 study that "will evaluate the potential of Afinitor plus best supportive care to extend progression-free survival and reach overall survival" in patients with pancreatic NET. Afinitor is currently approved in the US for the treatment of advanced kidney cancer if other treatments have failed.
Source: FirstWord
Merck KGaA's cancer vaccine Stimuvax
advances to Phase III testing for breast cancer
Merck KGaA reported Monday that the company is starting a late-stage trial of experimental cancer vaccine Stimuvax (BLP25 liposome vaccine) in patients with advanced, inoperable breast cancer. The STRIDE trial is expected to enroll more than 900 patients treated with hormonal therapy who have hormone receptor-positive, locally advanced, recurrent or metastatic breast cancer. The study will attempt to determine whether the vaccine can extend progression-free survival, and will also assess overall survival, quality of life, tumour response and safety, the company noted. Oliver Kisker, senior vice-president of Merck's oncology clinical development unit, said the therapeutic cancer vaccine is expected to be developed "within a robust clinical trial programme across several cancer types." The vaccine is already being evaluated in the late-stage START trial as a potential treatment for non-small-cell lung cancer. Kisker recently indicated that the company expects to file Stimuvax for regulatory approval in that indication in 2012. Merck acquired exclusive global licensing rights to Stimuvax from Oncothyreon.
Source: FirstWord Simponi receives FDA approval for treatment of arthritis