If the sipuleucel-T story were a movie, it would have most of the elements of a blockbuster: money, power, conflict, ethics, and even death threats.
What the prostate cancer vaccine doesn’t have, at least not yet, is the Hollywood ending: the "ah-ha" moment when the protagonist – in this case the first autologous cellular immunotherapy approved for any oncology indication – overcomes unbelievable odds and revolutionizes cancer treatment.
Instead, the momentum that propelled sipuleucel-T along the turbulent path to regulatory approval in April 2010 seems to have stalled. Acceptance in the prostate cancer market has been slower than expected, as sales fell substantially short of consensus estimates for the second quarter. Market analysts are skewering the manufacturer, Dendreon, for grossly overinflating expectations, and, at least in the business sector, the company’s claims that reimbursement concerns are at the root of the sluggish numbers seem to be falling on deaf ears.
Terms such as "implosion" and "derailment" in the business press have the ominous tone of a death knell for sipuleucel-T (Provenge), but oncologists and urologists in the trenches are more forgiving, albeit reasonably cautious. In an ironic twist, interviews show they want more data – a complaint that has dogged sipuleucel-T since the 2007 decision by the Food and Drug Administration’s Center for Biologics Evaluation and Research to act against its advisory panel’s favorable recommendations.
Instead of approval, the agency sent a complete response letter requesting further clinical evidence. Patient and lobbyist picketing outside of FDA offices and cancer conferences, death threats to panelists who had resisted approval, calls for congressional inquiries, and a lawsuit grabbed headlines but did not reverse the decision.
The Oncology Report
Comprehensive reports and expert commentary
on the latest advances in cancer treatment from
the world's major oncology meetings.
Past issues, click here »
|Mar 8 - 11|
|American Society of Preventive Oncology (ASPO): Annual Meeting|
|Mar 12 - 15|
|Society of Surgical Oncology (SSO): Annual Cancer Symposium|
|Mar 13 - 16|
|National Comprehensive Cancer Network (NCCN): Annual Conference: Advancing the Standard of Cancer Care|
|Mar 19 - 21|
|9th European Breast Cancer Conference (EBCC-9)|
|Mar 26 - 29|
|European Society for Medical Oncology (ESMO): European Lung Cancer Conference ELCC 2014|
|Mar 31 - Apr 2|
|Association of Community Cancer Centers (ACCC): Annual National Meeting|
|Apr 4 - 8|
|European Society for Therapeutic Radiology and Oncology (ESTRO): ESTRO 33|
|Apr 5 - 9|
San Diego, CA
|American Association for Cancer Research (AACR): Annual Meeting|
|May 8 - 10|
|Breast International Group (BIG)/ European Society for Medical Oncology (ESMO): IMPAKT Breast Cancer Conference|
|May 14 - 17|
|American Society of Pediatric Hematology Oncology (ASPHO): Annual Meeting|