Why Cancer Immunotherapy is Not Yet approved by the FDA

November 15, 2012 by  
Filed under Prostate Cancer News

One of the latest advances in cancer research is the development of vaccines. The vaccine is said to work on the immune system and help prevent further tumor growth.In other words, immunotherapy is the latest advancement in prostate cancer.

However, despite the effectiveness of this approach to cancer treatment (including prostate cancer), the Food and Drug Administration (FDA) of the US is yet to approve Immunotherapy fully as part of the conventional treatments for cancer diseases. Here is why:

While biologically based therapeutic cancer vaccines and other cancer immunotherapies have great promise in treating certain cancers, getting to “yes” for FDA approval is likely to remain challenging.

And, as knowledge and clinical trial experience about the nature of effective antitumor immune response to immunotherapeutics has emerged, it has become clear that valid endpoints and trial designs for conventional chemotherapeutic drugs need rethinking with respect to immunotherapy.

Despite enthusiastic market potential forecasts, with some predicting that the commercial market for cancer vaccines could increase to over $7 billion by 2015, only one therapeutic cancer vaccine has been approved to date in the U.S. In 2010, Dendreon’s Provenge, an autologous prostate cancer vaccine, became the first such therapeutic approved by the FDA.

The FDA had declined to approve it in 2007, against the recommendations of its own advisory committee, and required that the company undertake another clinical trial. In the first trial, of 127 patients, 115 patients had progressive disease at the time of data analysis, and all patients were followed for survival for 36 months.

The median for time to disease progression (TTP) for sipuleucel-T was 11.7 weeks compared with 10.0 weeks for treatment remained a strong independent predictor of overall survival; the median ratio of T-cell stimulation at 8 weeks to pretreatment was eightfold higher in Provenge-treated patients (16.9 v 1.99; P < .001). Provenge therapy was well tolerated.

While the improvement in the primary end point TTP did not achieve statistical significance, this study suggests that Provenge might have provided a survival advantage to asymptomatic hormone-refractory prostate cancer (HRPC) patients.

A second trial resulted in approval of the dendritic cell-based vaccine for the treatment of metastatic, asymptomatic HRPC. Results of the pivotal IMPACT clinical trial had shown that Provenge extended median survival by 4.1 months to 25.8 months from 21.7 months, sufficient for FDA approval in 2010.

Provenge’s approval pathway has been characterized by some as having “all the features of a heavyweight healthcare fight—desperate patients demanding access to a promising therapy with a very expensive drug that extends life only a few months and efficacy data open to interpretation.”

FDA Involvement

Michael D. Becker, founder and senior partner of MD Becker Partners, says the FDA does a “good job” with cancer immunotherapeutics. “The approval of Provenge was a watershed event,” he said, and required a lot of time and discussion on the agency’s part.

“I think the FDA in general has been very consistent in their mandate requiring two Phase III randomized clinical trials.” To Becker’s point, lymphoma autologous vaccine developer Biovest International announced that it had conducted a formal clinical guidance meeting with the FDA to determine the most expeditious U.S. registration pathway for BiovaxID last June.

At that meeting, the FDA required that Biovest conduct a second Phase III trial to confirm the clinical data generated in a successful Phase III trial (BV301). Results from that eight-year pivotal, randomized, multi-center, double-blind, controlled trial showed that its BiovaxID autologous cancer vaccine prolonged disease-free survival in follicular non-Hodgkin’s lymphoma, and with little or no toxicity. Click here to read more.

So, getting cancer immunotherapeutics approved is not only issues with the FDA, the above extract has shown that other factors could be standing in the way.

It becomes necessary to review these issues and weigh their impact on the overall health of patients who could have been saved after having been treated in some way with vaccines.

Stakeholders in the field of cancer treatments need to use larger population in clinical trials so that non approval of breakthrough medications would be less frequent.

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