16. September 2011 13:10
The FDA has changed the way it reviews new cancer drugs in the hope to make faster and better informed decisions.
The Agency’s Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganised and renamed the Office of Hemotology and Oncology Products (OHOP).
Janet Woodcock, CDER Director, said: “Under the new office structure, the Agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market.”
The new department includes four separate drug review units, aimed at increasing the level of expertise. The Division of Oncology Products 1 (DOP1), and Division of Oncology Products 2 (DOP2) units will each focus on a short list of solid tumours. The Division of Hematology Products (DHP) unit will assess haematological tumours, while the new Division of Hematology Oncology Toxicology (DHOT) will handle non-clinical pharmacology and toxicology regarding cancer therapies.
Dr Richard Pazdur, Head of the department, said: “As the practice of oncology and the treatments being developed for these diseases have become more complex, we’ve recognised the need and importance of taking a more disease-specific review approach to these therapies.”
He also added that the reorganisation aligns the FDA with the structure of leading cancer treatment centres, academic programmes and the National Cancer Institute.
The department’s previous system assessed drugs separately from biologics under three divisions: Division of Hematology Products (DHP), Division of Drug Oncology Products (DDOP) and Division of Biologic Oncology Products (DBOP).
24. August 2011 16:03
A new study has found that radioembolisation improves survival chances of patients suffering from hepatocellular carcinoma (HCC).
Hepatology reported that patients with tumours at different stages, including those with advanced liver cancer who had limited access to treatment options, are likely to benefit most from the procedure.
Dr Bruno Sangro from the Clinica Universitaria de Navarra in Pamplona, Spain said: “Our findings show strong evidence of the survival benefit with radioembolisation, even in patients with advanced disease who have few treatments options.”
Radioembolisation consists of a large dose of radiation directly delivered to the tumour via a small tube inserted in the groin. Tumours routinely become resistant to chemotherapy but not to these lethal doses of radiation.
An advantage of the therapy is that all the pretreatment and therapy is done on an outpatient basis so that only a limited amount of time will be spent by the patient in hospital.
The study assessed 325 HCC patients at eight European centres. Results revealed an average overall survival rate of almost 13 months with radioembolisation.
Almost 700,000 people died of HCC in 2008, with more than 80% of cases caused by hepatitis B and C infections, according to the World Health Organisation (WHO).
The National Cancer Institute estimates there will be 26,000 new cases of liver and bile duct cancer in the US by the end of 2011, resulting in 20,000 deaths.