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President Clinton has nominated Jane Henney for the position of Commissioner of the Food and Drug Administration.
Henney, 51, an oncologist and nationally recognized academic leader and public health administrator, worked at the NCI and the FDA during the Carter, Reagan, Bush and Clinton Administrations. If confirmed by the Senate, Henney would become the first woman to serve as FDA commissioner.
Since 1994, Henney has been the Vice President for Health Sciences at the University of New Mexico where she presided over consolidation of the university's hospitals, schools of medicine, nursing and pharmacy, and specialized facilities for mental health, cancer and pediatrics. From January 1992 to March 1994, Henney served as Deputy Commissioner for operations at the FDA, under then-Commissioner David Kessler. At the FDA, Henney managed the agency's daily activities, revitalized their six science centers, and implemented key legislation, including the Prescription Drug User Fee Act of 1992, the White House said in their June 23, 1998 statement.
"Henney revitalized FDA's centers for biologics, drugs, medical devices, foods, veterinary medicine and toxological research to make them more effective and efficient and to more closely align their research and review functions," the White House statement said. "In addition, she developed a strategic planning process and recruited new leadership for five of the agency's six centers."
From 1985 until joining the FDA, Henney served as Interim Dean of the University of Kansas School of Medicine, as Vice Chancellor for Health Programs and Policy, and as Acting Director of the Mid-America Cancer Center at the University of Kansas. She joined the NCI in 1976, rising from Senior Investigator in the Cancer Therapy Evaluation Program in the Division of Cancer Treatment to become NCI Deputy Director from 1980 to 1985 under then-NCI Director Vincent DeVita. At the NCI, Henney was "instrumental in the development of two innovative programs which engaged community-based oncologists in research and provided physicians and patients with up-to-date information on state-of-the-art therapy and investigational research protocols," the White House statement said.
"Dr. Henney has a proven track record at the FDA, and, if confirmed by the Senate, she will continue to shape the agency to respond to the changing nature of the industry and the health care marketplace," Health & Human Services Secretary Donna Shalala said. "Dr. Henney will encourage and nurture collaborative relationships with consumers and industry alike—this is crucial to FDA's success in the years ahead.
"A talented manager, Dr. Henney has the solid medical and academic credentials that are needed to understand the burgeoning field of biomedical research and development," Shalala said.
Henney has been a member of the American Society of Clinical Oncology (ASCO) since 1979. "As an oncologist and longtime member of ASCO, Dr. Henney brings an understanding of the needs of cancer patients and others with life-threatening illnesses," John Durant, ASCO Executive Vice President, said. "ASCO looks forward to working with Dr. Henney on remaining issues of concern to the oncology community." These issues include accelerating new and supplemental drug indications for life-threatening illnesses, and relaxation of restrictions on the dissemination of accurate information about off-label uses of drugs, as referenced in peer-reviewed journals, ASCO said in a statement.
Henney was born in Woodburn, IN. She received a B.S. in biology from Manchester College, Indiana, in 1969. She graduated from the Indiana University School of Medicine in 1973, and took an internship at St. Vincent's Hospital in Indianapolis, a medical residency in Atlanta, and a fellowship in oncology at M.D. Anderson in Houston. She is president of the United States Pharmacopeia, a non-profit organization that publishes the annual compendium of medicines used in the U.S. She serves on the Advisory Committee to the Director of NIH. Henney is married to Robert Graham, Executive Vice President of the American Academy of Family Physicians in Kansas City, MO.
Secretary Shalala also recognized Acting FDA Commissioner Michael Friedman, who has been leading the agency for the past 14 months since Kessler left. "I would like to commend Dr. Michael Friedman for the outstanding service and dedicated professionalism that he has demonstrated while serving as Acting FDA Commissioner," Shalala said. 
Surgical Oncology Group's Primary Goal to Evaluate Therapies for Patients with Malignant Solid Tumors, Wells Says
The first new national clinical cooperative group funded by the National Cancer Institute in 18 years, and the only one focusing exclusively on surgery, is now open for business.
The American College of Surgeons (ACoS) has received a $3.7 million annual grant from the NCI Division of Cancer Treatment and Diagnosis to support ACoSOG, the American College of Surgeons Oncology Group. Samuel Wells, new Director of the College of Surgeons, is principal investigator for the grant (a cooperative agreement) and is chairman of the group.
Wells said ACoSOG will conduct multicenter trials in surgical oncology, with the primary goal to evaluate surgical therapies in the management of patients with malignant solid tumors. Initially studied will be patients with the most common tumors, such as breast, lung, and colorectal cancers. The NCI Cancer Therapy Evaluation Program, which administers the Institute's support of the cooperative groups, is evaluating six ACoSOG protocols for studies in thoracic and breast oncology and malignant melanoma. ACoSOG is developing additional protocols.
ACoSOG will also evaluate selected new operations, technology, and instrumentation as they are introduced into clinical practice. In addition, ACoSOG will perform trials that are based on new basic science discoveries, such as new molecular markers in diagnosis and treatment and the role of interventional therapy in patients who are found to have a genetic predisposition for cancer.
Twenty institutions are presently full members of ACoSOG, and Wells said he expects many more to be involved in group studies through participation of ACoS member surgeons throughout the U.S. and also those members located in other countries. There are 65,000 members of the college, 45,000 of whom are active. Wells said he considers every one of them as potential investigators for ACoSOG.
Initial clinical trials planned by the group are:
All of these are prospective randomized trials except the correlative study, Wells said. "The lymph sentinel node studies are a further step to more conservative surgery," he pointed out.
The group's headquarters are at ACoS offices in Chicago. The biostatistical office is based with the Radiation Therapy Oncology Group at its headquarters in Philadelphia, but will move to Chicago over the first two years of the grant. ACoS is in the process of developing a large program in biostatistics to support additional clinical trials. The chief biostatistician is Brent Blumenstein.
Monica Morrow, Northwestern University, and Douglas Fraker, University of Pennsylvania, are Deputy Chairs of ACoSOG. As Director, Wells is Chief Executive of ACoS. He was Chairman of the Department of Surgery at Washington University in St. Louis, and was succeeded there by Timothy Eberlein.
Wells noted that the College has unique resources that are available to offer strong support to ACoSOG. These include the Cancer Department and its Commission on Cancer. Two of the Commission's programs, the Cancer Liaison Service (CLS) and the National Cancer Database, have important functions relative to clinical trials. The CLS is composed of 2,200 volunteer physicians, two-thirds of whom are surgeons. Approximately 1,500 of these physicians are located in the institutions with cancer programs that have been approved by the Commission on Cancer. Those physicians "will play a critical role as a link between surgeons participating in our clinical trials and our co-ordinating center in Chicago," Wells said. In collaboration with the CLS state chairmen, the physicians are expected to encourage and facilitate case accrual and the integration of surgical participation in ACoSOG trials at the state and local levels.
The National Cancer Database is funded jointly by ACoS and the American Cancer Society. The database collects demographic, clinical, and outcomes data on cancer patients from a network of cancer registries in both Commission-approved and nonapproved facilities. The Commission-approved cancer programs are responsible for the diagnosis and treatment of 80% of newly diagnosed cancer cases each year.
"The most important functions of ACoSOG are to generate new ideas for clinical trials which are scientifically important, attractive to participating surgeons, and designed to answer the questions posed in the study hypotheses," Wells said. "The critical determinant of success will be the group's ability to accrue patients to study."
There are 12 organ site groups in ACoSOG, each consisting of surgeons expert in the respective fields, medical oncologists, diagnostic and therapeutic radiologists, pathologists, biostatisticians, geneticists, patient advocates, nurses, and ethicists. Most of the clinical trials will originate in those groups, Wells said. The 12 groups are brain and central nervous system, breast, colon and rectum, endocrine, gynecologic, head and neck, ophthalmologic, pancreas and upper GI tract, pediatric, urologic, soft tissue and sarcoma, and thoracic. Pediatric and gynecologic trials will be integrated with those of the Pediatric Oncology Group, Children's Cancer Group, and the Gynecologic Oncology Group.
ACoSOG is administered and reviewed in the same manner and by the same offices as other NCI-supported cooperative groups. Primary responsibility for the groups is CTEP's Clinical Investigations Branch, whose Chief is Richard Ungerleider. Edward Trimble is the CIB staff member responsible for ACoSOG.
"The American College of Surgeons is grateful to NCI for supporting ACoSOG," Wells said. "The establishment of this cooperative clinical trials group provides an excellent opportunity for surgeons of all disciplines to design and conduct clinical trials that will comparatively evaluate surgical therapies in patients with cancer. We expect strong support from surgeons in this country and abroad."
Wells said ACoSOG has established strong working relationships with the surgical specialty societies and will work closely with them in developing protocols and addressing issues as they arise. ACoSOG's annual spring meeting will be held during the annual meeting of the Society of Surgical Oncology. The fall meeting will be scheduled to coincide with the November meeting of the Commission on Cancer. "The surgical specialty societies will be invited to participate in the development of clinical trials," Wells said. "This integration of surgeons from all disciplines across diverse geographical boundaries is unique to ACoS and offers an unprecedented structure for performing clinical trials."
Clinical Trials: Anti-HER-2 Monoclonal Antibody Plus Chemo Improves Breast Cancer Treatment in Study
A humanized anti-HER-2 monoclonal antibody (trastuzumab) commonly known by its trade name Herceptin, when used in combination with chemotherapy, slows the progression of cancer and increases tumor shrinkage in HER-2-overexpressing patients with metastatic breast cancer compared to such women receiving only chemotherapy, according to Dennis Slamon, reporting at the American Society of Clinical Oncology annual meeting.
"Herceptin is the first successful cancer treatment that targets a specific genetic alteration as opposed to using a shotgun approach that kills both diseased and healthy cells," said Slamon, Director of the Revlon/UCLA Women's Cancer Research Program at the University of California, Los Angeles. "Furthermore, Herceptin avoids the serious side effects associated with traditional chemotherapy, such as hair loss and significant drops in blood counts."
To reach these conclusions, a phase III trial was carried out to evaluate time to disease progression and safety in women who overexpress HER-2 and have metastatic breast cancer, comparing Herceptin plus chemotherapy and chemotherapy alone. A total of 469 such women with HER-2 plus metastatic breast cancer, who had not received chemotherapy previously for metastatic disease, received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 or paclitaxel 175 mg/m2, with all chemotherapeutic regimens given every three weeks for six cycles. Half the patients (stratified by chemotherapeutic regimen) were randomized to also receive Herceptin at a loading dose of 4 mg/kg i.v. on day 0 and then given a weekly dose of Herceptin 2 mg/kg i.v. throughout the course of the study until evidence of disease progression.
Key results as determined by an independent response evaluation committee showed that patients treated with Herceptin and chemotherapy had a significantly longer time to disease progression than women who received chemotherapy alone, Slamon said. The median time to disease progression was 7.6 months in the Herceptin plus chemotherapy group compared to 4.6 months in those on chemotherapy alone, a 65% increase with the addition of Herceptin. In addition, Slamon continued, the response rate in the women treated with Herceptin and chemotherapy was 49% (114/235) versus 32% (74/234) in the chemotherapy alone group, a 53% increase in favor of Herceptin addition. Also, the median duration of response was 9.3 months in the Herceptin plus chemotherapy-treated women, compared to 5.9 months in those on chemotherapy alone, an increase of 3.4 months.
Clinical benefits were observed in patients who received Herceptin in combination with either chemotherapeutic regimen, Slamon stated, but were greater with paclitaxel. In the Herceptin plus anthracycline group, 52% (75/143) of women had a response, compared to 43% (59/138) in women receiving doxorubicin and cyclophosphamide alone. In the Herceptin plus paclitaxel-treated patients, 42% (39/92) of women had an objective response versus 16% (15 of 96) in those on paclitaxel alone. Finally, quality of life was maintained with Herceptin and chemotherapy treatment.
As far as survival was concerned, Slamon said ultimately all women in this controlled trial could get Herceptin. This skewed the survival data.
It should be noted, said Charles Vogel, of Columbia Cancer Research Center in North Miami Beach who was an investigator in this study, "that in the 80 women treated in our portion of the study, there are women who have survived out two or three years. We have 11 women alive at one year, several at two years, and one woman still alive at five years. These women all were destined to die within five or six months without this treatment."
Genentech Submits Herceptin Data to FDA for Fast Review
Genentech Inc. has completed its submission of a Biologics License Application to the FDA for Herceptin, the company said. Herceptin is designated as a Fast Track Product by the FDA and will receive a priority review with a decision anticipated within six months. If approved, Herceptin will be a new biologic approach for the treatment of women with HER-2-overexpressing metastatic breast cancer. HER-2 overexpression affects 25% to 30% of breast cancer patients and is associated with more rapid cancer progression and shortened survival.
In addition to a phase III comparison trial presented at ASCO (as noted above), a second large clinical trial evaluated the response rate and safety when using Herceptin as a single agent. The study included 222 women with HER-2-overexpressing metastatic breast cancer who had relapsed disease following treatment with one or two prior chemotherapy regimens for metastatic disease. The overall response rate was 16% (34 of 213), with eight patients experiencing a complete response (4%) and 26 experiencing a partial response (12%). The median duration of response was nine months.
IVX BioScience Acquires ANDA for Paclitaxel from Immunex
IVX BioScience Inc. of Miami announced plans to acquire the Abbreviated New Drug Application (ANDA) for paclitaxel from Immunex Corp. of Seattle, the companies said. The planned transaction places IVX BioScience, formerly IVAX Pharmaceuticals, in control of two separate efforts to break the Bristol-Myers Squibb (BMS) control over the market for paclitaxel, sold under the brand name Taxol.
Before IVX BioScience and Immunex are able to generate any revenues in the U.S. market, they will have to overcome several obstacles:
Under the deal announced this June, IVX BioScience will pay Immunex an unspecified amount of cash for its ANDA for paclitaxel. If either drug is approved in the U.S., IVX BioScience and Immunex would collaborate on the marketing, the companies said. As part of the agreement, IVX BioScience will direct the Immunex litigation, and Immunex will reimburse IVX BioScience for a percentage of its paclitaxel patent litigation expenses relating to the ANDA applications, the companies said. If the Immunex ANDA is approved, IVX BioScience will pay Immunex royalties based on the net sales of the generic paclitaxel product. In addition, Immunex will help IVX BioScience promote the generic paclitaxel product using its oncology sales force, earning additional fees for this effort, the companies said.
In a separate agreement, IVX BioScience has appointed Immunex to promote Paxene, its branded form of paclitaxel, if that product receives final FDA approval. Immunex will earn fees based on all Paxene sales in the U.S. during the period in which it promotes Paxene.
This proposed transaction is subject to review by the Federal Trade Commission.
"Immunex and IVX BioScience believe it is important for cancer patients to have alternatives to the existing branded paclitaxel product as soon as possible, and the agreements announced are aimed at achieving this goal," David Bethune, the recently appointed Chairman and CEO of IVX BioScience oncology and U.S. generic pharmaceutical businesses, said in a statement. "If our efforts are successful, the marketing collaboration with Immunex will help IVX BioScience launch its new paclitaxel products more effectively."
"This alliance demonstrates a shared commitment to bring to market products competitive to Taxol with the potential of providing physicians with a choice of paclitaxel products," Ed Fritzky, Immunex Chairman and CEO, said in a statement. "Following FDA approval, Immunex and IVX BioScience will have a strong sales and marketing presence with which to compete with the Taxol franchise and ensure that patients have therapeutic options to this currently expensive cancer therapy," Fritzky said.
Under the deal, IVX BioScience will acquire the Immunex inventories of bulk paclitaxel. At this time, it is unclear who would supply bulk paclitaxel to IVX. A spokesman for Hauser, the company that supplied the active ingredient for the Immunex drug, said to The Cancer Letter that the company is negotiating the supply contract with IVX BioScience. Hauser's competitor, NaPro, is looking for a new development partner for paclitaxel, the company said.
IVX recently made a $3.75 million payment to its former supplier, NaPro BioTherapeutics, for a non-exclusive license to a patent for formulation of paclitaxel. The formulation method disclosed in the NaPro patent involves "mixing an acid with a carrier material, such as polyethoxylated castor oil, to form a carrier solution after which Taxol is added in an amount such that the resulting pH is less than 8.1, and preferably in a pH range of 5 to 7." The patent states that an anhydrous citric acid should be used in the formulation. The BMS formulation of the drug does not include citric acid.
In May of this year, IVX announced the name change from IVAX as well as administrative changes which included creation of a new unit to pursue activities in oncology. The unit will be comprised of Zenith Goldline and the oncology programs of IVX. The new unit's initial activities in oncology will focus on maximizing opportunities for Paxene, the company said. The unit will continue clinical trials of an orally active form of paclitaxel and will seek to license new products and to market generic oncology products, the company said.
Taxotere Approval Expanded to All Metastatic Breast Cancer
The FDA has given full and expanded approval to Taxotere (docetaxel) for Injection Concentrate, sponsored by Rhône-Poulenc Rorer Inc. of Collegeville, PA.
Approved indications for the drug now include first-line treatment of metastatic breast cancer in patients whose disease has recurred despite adjuvant therapy. Taxotere was previously limited to the treatment of patients resistant to anthracycline-based therapy. Data presented to the FDA included a side-by-side trial of Taxotere versus doxorubicin and Taxotere versus combination chemotherapy.
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