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Day Two

March 20, 1998

8120 Wisconsin Avenue

Bethesda, Maryland

Proceedings By:

CASET Associates, Ltd.

10201 Lee Highway, Suite 160

Fairfax, Virginia 22030

(703) 352-0091



Call to Order and Opening Remarks 1

Conflict of Interest Statement 1

Open Public Hearing II 3

NDA 20-262/S-026 Taxol (paclitaxel) Injection, Bristol-

Myers Squibb Pharmaceutical Research Institute

Sponsor Presentation 11

Questions from the Committee 33

FDA Presentation 52

Committee Discussion and Vote 78

NDA 20-262/S-026 Taxol (placitaxel) Injection, Bristol-

Myers Squibb Pharmaceutical Research Institute

Sponsor Presentation 83

Questions from the Committee 122

FDA Presentation 154

Questions from the Committee 173

Committee Discussion and Vote 197

P R O C E E D I N G S (8:00 a.m.)

Agenda Item: Call to Order and Opening Remarks

DR. DUTCHER: Good morning. This is the second day of the 56th Oncologic Drug Advisory Committee Meeting and we're here today to discuss two supplementation indications for paclitaxel (Taxol). We're going to be having some changes in the people at the table, so we're going to go around the table and introduce ourselves and then Dr. Somers is going to read a conflict of interest statement.

I'm Jan Dutcher from Albert Einstein Medical Oncology in New York.

[Introductions were made.]

Agenda Item: Conflict of Interest Statement

DR. TEMPLETON-SOMERS: Okay. I now need to read the conflict of interest statement for Taxol for the ovarian cancer indication. The following announcement addresses the issue of conflict of interest with regard to this meeting and is made a part of the record to preclude even the appearance of such at this meeting. Based on the submitted agenda and information provided by the participants, the agency has determined that all reported interests and firms regulated by the Center for Drug Evaluation and Research present no potential for conflict of interest at this meeting with the following exceptions.

In accordance with 18USC Section 208 and 505 of the FD&C Act, a full waiver has been granted to Dr. Kim Margolin. A copy of this waiver statement may be obtained by submitting a written request to FDA's Freedom of Information Officer located in Room 12A-30 of the Parklawn Building.

Further, we would like to disclose for the record that Dr. Schilsky and Dr. Swain have interests that do not constitute a financial interest in the particular matter within the meaning of 18USC 208, but which could create the appearance of a conflict. The agency has determined, notwithstanding these involvements, that the interests in the government in their participation outweighs the concern that the integrity of the agency's programs and operations may be questioned. Therefore, Dr. Schilsky and Swain may participate fully in today's discussions concerning Taxol for ovarian cancer.

Finally, we would like to disclose that Dr. Robert Ozols will be excluded from participating in all matters concerning Taxol.

In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, the participants are aware of the need to exclude themselves from such involvement and their exclusion will be noted for the record.

With respect to all other participants, we ask in the interest of fairness that they address any current or previous involvement with any firm whose products they may wish to comment upon. Thank you.

Agenda Item: Open Public Hearing II

DR. DUTCHER: Thank you. We're now going to proceed with the open public hearing, which will be for both the morning and the afternoon session. Our first speaker is Mr. A George Forbeck.

DR. TEMPLETON-SOMERS: Please give your name and any affiliation and any support from the pharmaceutical sponsor.

MR. FORBECK: George Forbeck and I have no sponsorship other than cancer.

Good morning. I gave Karen a fact sheet of a little bit about myself. It's short. I want to thank the committee for the opportunity to present my thoughts on Taxol. My protocol, when I was undergoing treatment for cancer, H. Lee Moffitt and the consideration, the knowledge and the ability of H. Lee Moffitt itself. My treatment was aggressive. My statement today will be short.

I have been most fortunate that I am a survivor of cancer and also have the privilege of serving on the Patients Rep Committee for the Eastern Cooperative Oncology Center. Also, all the committee members on the PCOG(?) Group are survivors and of more than one cancer in some cases.

In the late fifties, my father passed away of cancer in a veteran's hospital in Chicago. I had just come out of the Korean War and had never heard of cancer. I saw the pain and anguish that we went through because there was nothing at that time.

In 1983, my son Bill Guy, five of six children, was diagnosed with neuroblastoma, a childhood cancer. Despite the best efforts of the Mayo Clinic in Rochester, and the Rosewell(?) Park Pediatric Oncology Center, Billy passed away at the age of 11 in 1984. He had a quality of life at that time that wasn't bad, due to the expert help of the people at Rosewell and a protocol that was aggressive.

After Billy's death, my wife and I started a foundation that holds a scientific forum each year. A small group of leading cancer and research scientists are invited to participate in a roundtable discussion in the hope of building each other's ideas, knowledge and experience. The objective is to provide a forum for cross fertilization of ideas, concepts, observations in the hope of shortening the cancer research timetable.

My background is not one of scientific knowledge or medicine. My experience is living with the disease of cancer. In 1994, at the age of 67, I was diagnosed with Stage IIIB adenocarcinoma lung cancer at the Mayo Clinic in Jacksonville. I was told I would probably die within a year to two years. I was treated at the H. Lee Moffitt Center over a three month period. My protocol involved chemotherapy with a combination of Taxol and Cisplatin and my menu had other things on it, with radiation each day for approximately 36 days. Aggressive treatment, that's what I needed and that's why I'm here today, Taxol.

Within five months, I was pronounced in remission and I continue to be in remission today. The outstanding clinical help made Taxol work. I have to say this for the H. Lee Moffitt. I've sent approximately 50 to 100 people there over the past six years and our average is outstanding. The encouragement that you receive from Moffitt helps fight the disease.

Although three months of aggressive treatment was not pleasant, I was able to live somewhat normally. Most days I could walk at least a mile. I did have problems eating and lost about 30 or 40 pounds during the treatment. However, I weigh exactly today 181 pounds, the same as when I went in the Marine Corps in 1945.

I got to know some of the other patients who were following the same protocol as I was. In fact, I was delighted today because the nice lady right behind me is going to speak to you. We have had the same treatment and again Taxol has won.

I am convinced that the protocol using Taxol and Cisplatin was significant to my survival. Since my experience, I have recommended H. Lee Moffitt and their protocol to a number of others with similar diseases. I personally observed results far better than those of other protocols.

Since having my work on lung cancer at Moffitt, I also have had prostate cancer, which I'm a survivor of, with the new procedure at Moffitt. Just three weeks ago, I had four or five basal cells removed from my cheeks. So I am still a patient and still working at curing cancer.

The finale of this is a story about a friend of mine, Bernie from Wisconsin. It illustrates the success of Taxol and Cisplatin. Through friends of friends, I was put in touch with Bernie about four months ago. He had been diagnosed with the same type of cancer that I had in Chicago. His chances of survival were less than mine. I told him to point his car south and don't stop until you get to Tampa. He took my suggestion and two weeks he left in remission. I was at Moffitt two weeks ago. We were doing some work on the National Coalition for Prostate Cancer, and I watched Bernie get his last two hour treatment of Taxol. My treatments, I think they made a mistake, were somewhere between Monday until Wednesday night. But things have improved.

So anyway, that's my experiences. My work with cancer is ongoing. I spend probably somewhere between six and 10 days a month working with various parts of the disease. Our foundation is quite active and I'm delighted now to be associated with the Coalition of Prostate Cancer. Thank you so much. Any questions, I will be delighted to answer. Any thoughts about my treatment, byproducts, anything.

DR. DUTCHER: Thank you very much. We appreciate it.

The next speaker is Phyllis DeAngelis.

MS. DEANGELIS: Good morning. I want to thank you all for giving me this opportunity to speak to you. As I said, my name is Phyllis DeAngelis and the purpose of my coming here is to tell you that there is life after lung cancer and there's life with quality. Excuse me, that's not from my cancer.

Also, people who smoked shouldn't really be looked down on. We didn't know any better when we started smoking. The only thing we were told was don't smoke out on the street because you look cheap. Other than that, it was okay.

I was pretty well hooked and I was a smoker until the day I was diagnosed, which was in November of 1993. I was fortunate enough to end up at Foxchase Cancer Center in Philadelphia. I happened to be in the right place at the right time. I was diagnosed with Stage IIIB non-small cell lung cancer. I had an eight centimeter tumor and the outlook was very bleak.

I went for seven weeks of radiation and went home and thought that I would try and enjoy the rest of my life. I had five children and six grandchildren, so I had a lot to be thankful for, but I was only 56 and I really didn't want to die yet and I just didn't believe I was going to.

So, I found a little lymph node over here on the other side in my neck and I called the cancer center, went back up, was biopsied, and yes indeed, I had it in my lymph nodes. So we went for the clinical trial at that point. It was Taxol. I was put into the computer and randomly was chosen for the highest degree of Taxol and Cisplatin, supported by Nupogen(?) which was given to bring my blood back up where it needed to be. I also had that superior vena cava. There was no chance for surgery. I never say this right, the mediastinoscopy was done -- did I get through that? They said definitely, it was the original cancer that was in my lymph nodes.

So we started it and it wasn't fun. It was hard to find anything that was really appealing to eat and I did lose quite a bit of weight. I was down below 100 pounds. And here I am all these years later. I've had no recurrence of any kind. Today, I chose to come here rather than to go to my sister-in-law's funeral in New York State. She is being buried this morning. She died of lung cancer. She did not go to a cancer institute. She was not offered a protocol. I know she would be happy that I am here instead of up there today.

It's just so important that lung cancer be brought out, you know it's kind of put in the closet. All we ever hear about is breast cancer, we hear about AIDS, we hear about prostate cancer. I never knew until I came down here that somewhere there is a little group, a support group for people that have had lung cancer. I've been to a lot of cancer facilities. But you're kind of pushed aside, well, you smoked, you know, but there are lot of people that were in that program that didn't smoke and had lung cancer.

It's something I just have to really sincerely hope that the message will get out that there is life after lung cancer. Cisplatin is the thing, Cisplatin with Taxol was my answer. I know that the Cisplatin got to be a little bit toxic for me. After all my required treatments for that, the Cisplatin was dropped and I stayed on Taxol for several more months. In January of 1995, there was no more tumor. Today, there is no more tumor. All they see is just a little scarring.

So, I don't know what else I can say, I'm not much of a speaker, and I don't know what else I can say except that I think maybe this is what I was spared for. The good Lord had to have a reason to leave me here. I buried my husband last summer, so I guess now my job is to see to it that other people that are faced with these same problems can get the same kind of help that I got. Thank you very much. Does anybody have any questions?

DR. DUTCHER: Can you just tell us whether you have any sponsorship from the sponsor?

MS. DEANGELIS: I was asked by my doctor in Foxchase if I would be interested in doing this and I said yes. A few days later, I received a phone call and was told that Dr. Cory Langer(?) from, he was the head of the ECOG(?), that he would be happy to pay my expenses to come down. But regardless, I would have come down anyway. Thank you.

DR. DUTCHER: Thank you very much for sharing.

Is there anyone else in the audience that wishes to speak before we go on with the presentations?

Once again, thank you to the individuals who took the time to come and talk to us, we appreciate it.

Okay. With that, I think we will go ahead with the sponsor's presentation. We are going to be talking this morning about Taxol indicated as first-line therapy for the treatment of advanced carcinoma of the ovary.

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