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doi: 10.1097/01.COT.0000292598.50977.10
Department: Eye on Washington
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FDA Orders New Labeling for Gefitinib, Drug's Future on Shaky Ground

The FDA has ordered new labeling for gefitinib (Iressa) that limits the indication to cancer patients who, in the opinion of the treating physician, are currently benefiting, or have previously benefited from the agent.

AstraZeneca, the drug's manufacturer, plans to limit distribution under a risk-management plan called the Iressa Access Program.

Under the program, prescriptions for gefitinib will be limited to the following patients:

  • ▪ Those currently receiving and benefiting from the drug.
  • ▪ Patients who have previously benefited.
  • ▪ Those currently or previously enrolled in clinical trials of gefitinib prior to June 17 of this year.

Gefitinib is an epidermal growth factor receptor tyrosine-kinase inhibitor that received accelerated approval in May 2003 for patients with non-small cell lung cancer (NSCLC) that was refractory to established regimens (platinum drugs and docetaxel)—despite a response rate of only 10% on the basis of a surrogate endpoint.

In the time since gefitinib appeared on the market, another NSCLC drug has been approved: erlotinib (Tarceva), which demonstrates increased overall survival compared with gefitinib.

When a drug receives accelerated approval, the FDA requires the manufacturer to perform additional, confirmatory, clinical trials. AstraZeneca complied, but the trials failed.

One of the two additional gefitinib trials enrolled 1,692 patients and compared it with a placebo. There was no survival advantage. According to FDA, “Three other studies of gefitinib in patients with lung cancer have also failed to demonstrate improved survival. However, AstraZeneca continues to examine the data and intends to pursue additional clinical studies,” which is the basis of the Iressa Access Program.

The FDA has expressed concern that gefitinib, instead of other approved treatments for NSCLC that increase survival such as erlotinib and docetaxel, might be used in new patients, thus putting them at a survival disadvantage.

Agency regulations allow it to withdraw a drug from the market “more quickly than usual” if the post-approval studies do not demonstrate clinical benefit. It is not considering withdrawing gefitinib, however, “at this time,” the Agency noted.

Still, it might. When the number of patients taking the drug in the access program falls below a certain level, the drug can either be removed from the market or the indication changed. If it is removed, the FDA will consider authorizing continued access under an investigational new drug protocol for patients who are benefiting from the agent.

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ACCC Survey: Most Physicians Will Not Participate in Competitive Acquisition Program

The Association of Community Cancer Centers (ACCC) recently surveyed oncologists on their interest in participating in the Competitive Acquisition Program (CAP). Most of the respondents surveyed said they will not participate but are more likely to work through a CAP vendor if they cannot obtain drugs for less than average sales price (ASP) plus 6%. Many said they viewed CAP as administratively burdensome.

“As proposed in the draft rule, CAP is not going to work until CMS recognizes the extensive administrative resources that physicians electing it will incur,” said Deborah Walter, ACCC Senior Director for Policy and Government Affairs.

“Failure to address the administrative burden and additional resources that the program may require could discourage participation in CAP and undercut the enhanced access to cancer drugs that might otherwise be obtainable.”

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Congress Asks CMS to Extend Quality of Cancer Care Demonstration Project

Rep. Ralph Hall (R-TX) introduced HR 261, which asks the Centers for Medicare & Medicaid Services (CMS) to refine and extend its demonstration project to assess the effects of chemotherapy. The resolution recognizes CMS for implementing the project and says it should be extended at least through the end of next year.

Also, that the project should be modified, if appropriate, to collect more data relating to the quality of care provided to Medicare beneficiaries with cancer. Payments to physicians for participation should continue, to ensure that Medicare patients have access to chemotherapy.

ASCO commended Rep. Hall for his leadership and called on other Congressional leaders to support the resolution. “ASCO's priority remains a focus on long-term solutions rather than short-term stopgap approaches,” said the Society's Immediate Past President, David H. Johnson, MD. “ASCO looks forward to continuing the dialogue with Congress and CMS in an effort to find a solution that will extend and make permanent the benefits of the demonstration project.”

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CDC Announces Major Reorganization

As a result of threats of bioterrorism and potentially devastating viral outbreaks, the Centers for Disease Control and Prevention has reorganized. The proposed changes, the organization noted in a statement, will enable CDC to pursue its mission in preparing for new and unpredictable health threats and protecting health and quality of life.

“Transforming our health care system to help Americans live longer, healthier, and better lives is our challenge in the 21st century,” said Health and Human Services Secretary Michael Leavitt.

The new structure includes creation of four coordinating centers and two national centers. The coordinating centers will be concerned with environmental health and injury prevention, health promotion, infectious diseases, and health information and services.

The National Center for Public Health Informatics will apply computer and information sciences to translate scientific data into usable information. The National Center for Health Marketing will use research and science to develop messages that help Americans make sound health decisions.

“CDC is now a 21st century agency ready for the challenges of 21st century health threats,” said CDC Director Julie Gerberding, MD, MPH. “As any corporation or large organization will tell you, realignments are tough to achieve.

“The exciting part is the payoffs we're already seeing as we emerge from this initiative as a modern, flexible, goal-oriented agency.”

With the new structure, the expectation is that CDC scientists will be better able to share their expertise to solve health problems.

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FDA Clarifies Submission Requirements for Exploratory Studies

In a new draft guidance, the FDA has clarified submission requirements for early Phase I exploratory studies under an investigational new drug application (IND).

The Agency says that these applications often contain more data than required. According to the draft guidance, depending on the individual IND, preclinical testing programs can be less detailed and more flexible than for traditional INDs.

The guidance defines an exploratory IND study as a clinical trial that occurs very early in Phase I, involves very limited human exposure to a product, and has no therapeutic intent. Such tests are used to select the most promising lead product from a group of candidates designed to interact with a particular therapeutic target in humans.

The FDA developed the guidance document with input from NCI through the intra-agency Oncology Task Force (OTF), which fosters close cooperation between the agencies.

“We were looking for ways to streamline the early drug-development process,” said Michaele Christian, MD, Associate Director of NCI's Cancer Therapy Evaluation Program.

“The goal is to allow researchers to conduct early proof-of-principle evaluations of compounds and target effects that identify promising candidates for more extensive testing.”

The FDA and NCI have noted that it will be especially beneficial to have a series of analogues if a researcher cannot or does not want to make a decision about which agent to move forward with. The guidance will allow investigators to test each analogue in a limited way to provide sufficient human data to help inform the decision.

Although the FDA's regulations are flexible, many researchers and drug sponsors have not taken full advantage of that flexibility and limited early Phase I studies.

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Clinical Trials Data Bank

Senator Christopher Dodd (D-CT), with three co-sponsors, has introduced the Fair Access to Clinical Trials Act of 2005 (S 470). The bill would require the Secretary of Health and Human Services to establish and operate a data bank of information on clinical trials, including a registry of health-related interventions to test the safety and efficacy of drugs, biologicals, and devices, as well as a database of the results of such trials.

In addition, the FDA would be required to make public its full reviews of new or supplemental drug applications as well as copies of written considerations of a drug's safety conducted by the Office of Drug Safety.

The HHS Secretary would have the authority to impose monetary penalties for failure to comply with the reporting requirements and to correct inaccurate, false, or misleading information.

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New Sexual Health Program at MSKCC

In an effort to treat the sexual health problems commonly caused by cancer and its treatment, Memorial Sloan-Kettering Cancer Center has created the Sexual Health Program for Women. The Program treats both current and former cancer patients.

“I think the topic is central for survivorship,” Jeanne Carter, PhD, Sexual Health Counselor for the Program, said in an interview. “I would say there's a desperate need for it, because a lot of women who go through cancer treatment really do experience some sort of change in sexuality and intimacy.”

Dr. Carter, who is certified by the American Association of Sex Educators, Counselors, and Therapists, noted that the Program provides a comprehensive psychosexual and gynecological evaluation, which includes patient history, physical examination, and any necessary laboratory tests, and it may use physical therapy, hormonal manipulation, counseling, and alternative therapies to treat sexual problems.

Lifestyle issues that affect sexuality, such as diet, exercise, and stress management, may also be discussed during visits.

“The goals of the Program are fourfold—clinical care, patient education and support, medical training and support, and scientific research,” said Michael L. Krychman, MDCM, Co-director of the Program. “My goal is to help cancer survivors live life strong and full. It's not just about sex—it's about closeness, intimacy, connectedness.”

In addition, since sexual health problems affect not only the female cancer survivor, the treatment process often includes the patient's partner.

© 2005 Lippincott Williams & Wilkins, Inc.
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