Greetings from Chicago, where I host a breast cancer education event this week. I just got back from Washington, D.C., where I testified before an FDA advisory hearing of the Oncologic Drug Advisory Committee. I am still reeling from what happened there and wanted to share it with you because it says a lot about where we are with drug development and cancer drug approvals.

Here goes:

First, let me explain who was at this meeting. The FDA calls on advisory committees of physicians, biostatisticians, consumer advocates and patients to answer key questions about drugs, medical devices, diagnostic tests, etc. that have applied for FDA approval.

This week, the advisory committee on cancer drugs met in Silver Spring, Md. outside Washington, D.C. The morning session was about a proposed CLL drug, Genasense. It's a little like a debate and a little like a legal proceeding. The FDA gives its opening remarks – in this case putting Genasense in a negative light right from the start – and then the sponsor (in this case a fairly early stage biotech company with hundreds of millions of dollars at risk), presents its data on how its proposed new drug can make a difference. Then there's a lot of discussion.

The company in discussion was Genta, which had already been bashed by the FDA once before when data didn't look promising enough for Genasense in malignant melanoma. Now the company was making its case in CLL, my condition, and I was there to make a plea for having more drugs in our doctors' tool kits. Alongside me were other patients who had received Genasense (I had not) and felt they were alive today because of it.

The hearing took all morning. A dream team of CLL specialists were there including: M. D. Anderson doctors Michael Keating and Susan O'Brien, Bruce Chesson from Georgetown, and Kanti Rai (the grandfather of CLL care) from Long Island Jewish. Dr. John Reed, another hematologist superstar, was also there as were others I know less well. They feel Genasense works as a chemosensitizing agent, in some people who are failing, help them do better with Fludara (fludarabine) and Cytoxan (cyclosphosphamide) than if those drugs were used alone. The data showed a 10 percent benefit. More simply put, one in 10 patients who received it had real improvement and often a very significant remission. For the FDA, this was not significant because they saw too many others who didn't get much benefit and thought the expense wasn't worth it – if who could or couldn't receive the drug wasn't able to be pre-determined. Most of the panel agreed and voted 7 to 3 against the drug. It was effectively a nail in the coffin for Genasense and maybe for Genta as a company too – although I am not an investment type, so take that comment with a big grain of salt.

Here's the shame of it all. There are real people who would be dead who received Genasense and are alive today and doing well. The CLL specialists are begging for a new drug to help people who aren't responding well to Fludarabine used alone or with other "on the market" drugs. The experts like Susan O'Brien believe Genasense is worthwhile and that a first-in-class chemosensitizing agent is important.

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