Alpharadin - fra ide til medikament.

Abstract

Alpharadin, a new drug used in the treatment of skeletal metastases in prostate cancer patients, secured an FDA approval in May 2013 and an EMA approval is not far away. Algeta, the company behind the drug, has high expectations for Alpharadin. Clinical studies, including the large phase 3-study ALSYMPCA, have shown convincing results. Alpharadin is an intravenous, bone-seeking radiation therapy that may be of great use in patients with castration-resistant prostate cancer and breast cancer where the cancer has spread to the bone. The treatment consists of injections with radium chloride solution. The radioactive radium isotopes (radium-223) will precipitate in bone tissue, primarily in skeletal tumors, and emit short-ranged, energy-rich alpha-radiation that kills nearby tumor cells. Preclinical trials with radium-223 have shown that the isotope, when injected systemically, has a favorable biodistribution (high uptake in bone tissue and low uptake in soft tissues), a low toxicity and, last but not least, a therapeutic effect on skeletal metastases. It has also been shown that radium-223 is excreted safely from the body, primarily via the intestines. Clinical phase 1 and 2 trials have shown increased survival and reduced levels of ALP and PSA in patients receiving Alpharadin treatment and confirmed that the toxicity of the drug is low. The phase 3 trial (ALSYMPCA) found a significant increase in overall survival and time before an SRE in the group treated with Alpharadin compared to the group treated with placebo (median survival: 14.9 vs 11.3 months; median time to first SRE: 15.6 vs 9.8 months). In addition, ALP values were greatly reduced, and the side-effect profile was mild. These findings indicate that Alpharadin in the near future may become an important drug in the therapeutic armamentarium of skeletal metastases.

Alpharadin, a new drug used in the treatment of skeletal metastases in prostate cancer patients, secured an FDA approval in May 2013 and an EMA approval is not far away. Algeta, the company behind the drug, has high expectations for Alpharadin. Clinical studies, including the large phase 3-study ALSYMPCA, have shown convincing results. Alpharadin is an intravenous, bone-seeking radiation therapy that may be of great use in patients with castration-resistant prostate cancer and breast cancer where the cancer has spread to the bone. The treatment consists of injections with radium chloride solution. The radioactive radium isotopes (radium-223) will precipitate in bone tissue, primarily in skeletal tumors, and emit short-ranged, energy-rich alpha-radiation that kills nearby tumor cells. Preclinical trials with radium-223 have shown that the isotope, when injected systemically, has a favorable biodistribution (high uptake in bone tissue and low uptake in soft tissues), a low toxicity and, last but not least, a therapeutic effect on skeletal metastases. It has also been shown that radium-223 is excreted safely from the body, primarily via the intestines. Clinical phase 1 and 2 trials have shown increased survival and reduced levels of ALP and PSA in patients receiving Alpharadin treatment and confirmed that the toxicity of the drug is low. The phase 3 trial (ALSYMPCA) found a significant increase in overall survival and time before an SRE in the group treated with Alpharadin compared to the group treated with placebo (median survival: 14.9 vs 11.3 months; median time to first SRE: 15.6 vs 9.8 months). In addition, ALP values were greatly reduced, and the side-effect profile was mild. These findings indicate that Alpharadin in the near future may become an important drug in the therapeutic armamentarium of skeletal metastases.