FDA approves Provenge for prostate cancer

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Amongst the daily catch of healthcare-related news releases, some announcements are just more important than others. That's certainly the case with Dendreon's announcement that the FDA has approved Provenge (sipuleucel-T), autologous cellular immunotherapy for the treatment of asymptomatic or minimally symptomatic metastatic, castrate-resistant (hormone-refractory) prostate cancer (CRPC). Provenge is designed to induce an immune response against prostatic acid phosphatase (PAP), an antigen expressed in most prostate cancers. 

It's not just the promise of improved treatment for sufferers of prostate cancer that make the drug stand out, however. It's the fact that it's the first in a new therapeutic class known as autologous cellular immunotherapies. And it's been a long time coming.

Says Mitchell Gold, M.D., Dendreon President and CEO, "The FDA approval of Provenge is a testament to the courage of the patients and researchers who participated in our studies and is the culmination of nearly 15 years of research and development by our dedicated employees."

According to Philip Kantoff, M.D., Director of the Lank Center for Genitourinary Oncology, Chief of the Division of Solid Tumor Oncology, and Chief Clinical Research Officer at Dana-Farber Cancer Institute, Professor of Medicine at Harvard Medical School. "Cancer immunotherapies that use the patient's own immune system will likely create an entirely new treatment paradigm for patients with cancer."

Dendreon plans to make Provenge available through approximately 50 centers, all of which also served as approved clinical trial sites.

- see Dendreon's release

ALSOL Mentor Capital has noted that with the featuring of Dendreon's Provenge prostate cancer vaccine on Fox News, cancer immunotherapy has come to a new point of popular acceptance. "One year ago only biotech investment reviews and medical journal reports followed pioneering cancer immunotherapy index member, Dendreon, as it climbed 1,000% in forty-five days." Mentor predicts other Dendreon-like companies in its "Cancer Immunotherapy Index (CII)" will also likely see a positive reaction. "Other CII companies are also pursuing treatments targeting cancer stem cells or brain, breast, melanoma and other cancer immunotherapies. Quite possibly, two or three markets of equal or greater size to Dendreon's will evolve, simply because there are two or three times the occurrence of cancer in the other cancer types that those companies are working on." Release

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