NEW YORK (Reuters Health) Sept 12 - Treatment with vitamin C or ascorbate at high levels, which can be attained if administered intravenously, can selectively destroy cancer cells, new research indicates.
(full story…)

Prostate cancer patients are lobbying the FDA for approval of Abbot’s oral anti-cancer drug Xinlay (atrasentan), but the FDA is not impressed with the drug.

Abbott Laboratories Inc. did not provide clear evidence of effectiveness for Xinlay, U.S. Food and Drug Administration staff said in a preliminary report on Monday.

Studies of Xinlay also raised “serious cardiovascular safety issues,” the FDA staff said in a report posted on the FDA’s Web site.

In the only trial sufficient to evaluate for approval, Xinlay “does not demonstrate any clear evidence of clinical efficacy” in prostate cancer that has failed to respond to standard hormone therapy, the FDA staff report said.

Abbott, in a separate summary on the FDA Web site, said “the weight of evidence suggests that (Xinlay) provides measurable clinical benefit with a manageable safety profile.”

A panel of experts from outside the FDA is scheduled to decide Tuesday whether to recommend Xinlay for approval. The committee will consider the FDA staff comments, as well as arguments from Abbott.
(full story…)

FDA’s Oncologic Drugs Advisory Committe hearing in Washington, DC on Abbott Lab’s application for approval of Xinlay (Atrasentan) will be held Sept 13. Details for this and other drug applications scheduled for hearings on 13th and 14th, below.

Center: CDER

Date and time:
September 13, 2005, 8:00 a.m. - 5:00 p.m.
September 14, 2005, 8:00 a.m. - 5:00 p.m.

Location:
Holiday Inn
The Ballrooms
8120 Wisconsin Ave.
Bethesda, MD

Open Public Hearing: Oral presentations from the public will be scheduled
between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on both
September 13 and 14, 2005.

Agenda:
On September 13, 2005, the committee will discuss the following: (1) new drug application (NDA) 21-491, proposed trade name XINLAY (atrasentan hydrochloride) Capsules, Abbott Laboratories, proposed indication for the treatment of men with metastatic hormone-refractory prostate cancer; and (2) NDA 21-743, S003, TARCEVA (erlotinib) TABLETS, OSI Pharmaceuticals Inc., proposed indication for the first-line treatment, in combination with gemcitabine, of patients with locally advanced, unresectable or metastatic
pancreatic cancer.

On September 14, 2005, the committee will discuss the following: (1) NDA 21-880, proposed trade name REVLIMID (lenalidomide), Celgene Corp., proposed indication for the treatment of patients with transfusion-dependent anemia due to low-or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; and (2) NDA 21-877, proposed trade name ARRANON (nelarabine) Injection, GlaxoSmithKline, proposed indication for the treatment of
patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed with, at least two chemotherapy regimens.

Background material and meeting information will become available no later than one business day before each meeting day (Simply scroll down to the appropriate committee heading).

Procedure (Open Public Hearing):
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by September 2, 2005. Oral presentations from the public will be scheduled between approximately 10:30 a.m. to 11 a.m., and 2:30 p.m. to 3 p.m. on both days. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before September 2, 2005, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Johanna Clifford at 301-827-7001, at least 7 days in advance of the meeting.

Contact Person:
Johanna M. Clifford, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, Rm. 1093) Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: [email protected]

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512542.

NPCC Suspends Regular Screenings, Lends Support to Hurricane Survivors
A big purple vehicle identified with the fight against cancer is now in the race to save lives in New Orleans.

The Drive Against Prostate Cancer, the world’s most successful mobile prostate cancer screening vehicle (over 35,000 tests in four years), has switched operations to help the survivors of Hurricane Katrina. Full Story “Upfront”

ASCO - Hurricane Katrina Message Board
Date: September 07, 2005, 01:48 AM
From: Physicians Relief Org.
Location: Baton Rouge, LA

We have four physicians in the area and can provide transportation for patients needing to reach oncology practices to continue ongoing treatment. Please call us at 434-227-6900 if the need arises.

The Drive Against Prostate Cancer is headed to Louisiana as soon as we get a
location from the command center. The vehicle will be used for general
medical care. We are doing what we can to help during the crisis. Prostate
Cancer Awareness Month is about saving lives, we are just doing it a little
differently this year. The next prostate cancer screening event with the
Drive will be at Cruisin’ for a Cure in California on September 23 and 24.

–Skip

Skip Lockwood
Executive Vice President and COO
National Prostate Cancer Coalition

Ron Seitzer, who lives in the French Quarter of New Orleans, washing his clothes in the Mississippi River. AP photo from nola.com

ASCO HURRICANE KATRINA MESSAGE BOARD for cancer patients looking for their doctors or to communicate with other doctors.
Message boards at New Orleans Times-Picayune online (nola.com) for anyone needing to reach out or wanting to volunteer.

Life’s Necessities Grow Scarcer at the Superdome By Wil Haygood Washington Post Staff Writer Saturday, September 3, 2005; Page A01

“A man walked up, wearing a T-shirt, work pants and moccasins. Raymond Williams had been a nomad for four days. ‘My wife’s got cancer,’ he said. ‘Throat cancer. And I got prostate cancer.’ He was accompanied by his wife, Leona, and 15 grandchildren. They were carrying their belongings in plastic bags. The Superdome was in the distance, like a painful mirage. ‘Both me and my wife are on medication. Leona, show him your neck.’

She pulled down a handkerchief that had been tied around her neck. The bandages that covered the incisions made from her throat cancer surgery were the color of river water. ‘We holding on through the grace of the Lord,’ Leona Williams said, in a pink blouse that somehow still looked very nice and pretty.

Every minute or so, Raymond Williams would twirl his neck, gathering his grandchildren close as possible, only to have them ease back out into the road, like figures on a bobbing raft.

Washington Post

Asistencia para recuperación en caso de desastre
Desinfección de emergencia del agua potable
Lo que puede hacer para ayudarse a sí mismo después de un desastre
Recuperarse después de un huracán
Organizaciones
En Espagnol

If you are a displaced cancer patient or family member and need cancer information or referral, call the Cancer Information Service at 1-800-4-CANCER (Monday through Friday 9:00 am -4:30 pm local time) or click on the “LiveHelp” icon on this page to chat online with NCI Information Specialists (Monday -Friday 9am-11 pm EST).
NCI Responds to Hurricane Katrina

* Call 301-496-5725 if you are participating in a NCI-sponsored clinical trial in a hospital or oncology practice located in the hurricane-affected region. This line will be answered from 8:30 am to 5:00 pm (Eastern Time). After hours and on weekends, callers can leave a message and an NCI employee will respond within an hour. Provide as much information as you can about the clinical trial (for example Protocol number, type of cancer, name of test drug) to help NCI Information Specialists direct you to the appropriate resources.

# SELECT trial participants - Please check the Southwest Oncology Group’s SELECT Web site to locate a SELECT study center near your new location.

# STAR trial participants - Please check the National Surgical Adjuvant Breast and Bowel Project’s STAR Web site to locate a STAR study center near your new location.
NCI responds to Hurricane Katrina

WebMD doctor Harold Burstein gives advice:

“Cancer patients, like others with chronic health problems, require regular, ongoing health delivery. Cancer patients typically receive chemotherapy or radiation therapy treatment on fixed schedules, such as daily radiation treatment for 5 weeks, or chemotherapy treatment every 2 weeks, and so forth. Disruptions in the scheduling and delivery of cancer treatment can interfere with optimal treatment outcomes….
Question: What should cancer patients actively being treated do right now?

The short term needs of the patient will differ depending on the tumor type, the treatment, and the available medical resources…”

WebMD

A list of oncology practices in Louisiana, Mississippi, and Texas–as well as in several other states–that have indicated that they are able to care for patients in need of treatment during this time. Patients can call the doctors’ offices or cancer centers listed below to learn more about how they can receive treatment while they are unable to access their primary care facility. asco.org

9/2/05—ASCO Joins the Effort to Help Cancer Patients in Hurricane-Stricken Areas
To help its members and their patients, ASCO has compiled this list of oncology practices, cancer centers and hospitals in the surrounding region that are operational and able to absorb patients in need of acute care.

The Department of Health and Human Services, Office of Public Health Emergency Preparedness (O PHEP) is in the process of identifying and mobilizing healthcare professionals and relief personnel to assist in Hurricane Katrina relief efforts. As our nation and the global community is now aware, the healthcare needs resulting from Katrina has reached an extremely critical nature. HHS has released details on types of assistance needed and how to volunteer here.

The Centers for Medicare & Medicaid Services has acted to assure that the Medicare, Medicaid and State Children’s Health Insurance Programs will flex to accommodate the emergency health care needs of beneficiaries and medical providers in the Hurricane Katrina devastated states. Following a waiver signed yesterday by HHS Secretary Leavitt, many of the programs’ normal operating procedures will be relaxed to speed provision of health care services to the elderly, children and persons with disabilities who depend upon them. Details of these provisions may be found at www.cms.hhs.gov/hki/. Also, the full text of a letter from CMS Administrator, Dr. Mark McClellan, may be found here.

Several practices have indicated they are open and able to take cancer patients who have been dislocated and are in need of acute care. The list of practices can be found here.

The Hurricane Katrina Message Board has already begun to work in reconnecting providers and patients. If you have been dislocated from your practice, or if you are seeking to contact a provider whose patient you are now treating, post your message on the Katrina Message Board.

Read more at www.asco.org.