FDA Approves First Immunotherapy Vaccine for Cancer

Provenge, an immunotherapy for patients with advanced prostate cancer, has become the first therapeutic vaccine for cancer ever approved by the FDA. Clinical research found Provenge, manufactured by Dendreon Corporation, extends survival in patients with late-stage prostate cancer by 4 months, from 21.7 months to 25.8 months, and increases 3-year survival by 38%. The survival time is nearly double that of Taxotere (docetaxel), the only approved chemotherapy for advanced prostate cancer. Researchers expressed both joy and relief, as the quest for a prostate cancer immunotherapy has taken decades, and the FDA previously rejected Provenge in 2007. The vaccine’s main side effects include chills, fever, fatigue, joint ache, and headache, which are reportedly less severe than Taxotere’s. Ongoing research is already attempting to extend Provenge’s reach to treatment at earlier stages and in combination with chemotherapy. The one damper on the otherwise positive news: Provenge will cost between $70,000 to $100,000 for a course of treatment. With insurance companies requiring copayments of up to 20%, most patients will struggle to cover the bill.

Oncology Net Guideasked its advisory board members what they thought of the FDA’s approval of Provenge. Here is what two members had to say about it:

“The approval of Provenge is indeed a big advance in not only the treatment of metastatic prostate cancer, but potentially for many other types of cancer as well. The fact that the study was able to show a statistical increase in overall survival is significant. This breakthrough can lead to therapeutic vaccines in other immunologically sensitive cancers as well, such as melanoma and renal cell cancer.”

—Helen Chan, MD, director of GI surgical oncology, Lakeland Regional Cancer Center, Lakeland, FL

“The 4-month improvement in survival is definitely clinically significant, especially in the setting of a patient population who are often very elderly and debilitated. These positive results are important for the treatment of prostate cancer, of course, but also provide an important proof of principal that I believe will help to counter the pessimism that has long pervaded the oncology community after decades of relatively disappointing results from research with immune-based therapies. However, the pricing at $93,000 per patient is unfortunately so aggressive that it begs the question of whether our healthcare system can afford palliative treatments regardless of the cost. It suggests that companies pricing cancer therapeutics have no incentive to price their products below a level that could be considered extortionate and clearly out of reach for patients who would have a significant copay. I can only hope that Dendreon will offer a comprehensive patient assistance program to prevent the conclusion that they are far more inclined to prioritize exceptional profits over the benefits Provenge can offer its target population.”

—H. Jack West, MD, medical director, Thoracic Oncology Program, Swedish Cancer Institute, Seattle, WA