NCI Puts Genentech Studies On Hold, Citing IP Disagreement

From The Cancer Letter, March 12, 2010:

NCI placed a hold on new studies of three Genentech cancer drugs, citing ongoing disagreement over intellectual property provisions of the standard cooperative research and development agreements used by the institute.

The hold on new studies was announced by the NCI Cancer Therapy Evaluation Program in an email to clinical investigators March 3. The hold affects Avastin (bevacizumab) and two new drug candidates, hedgehog pathway inhibitor GDC-0449 and Bcl-2 inhibitor ABT-263. All three drugs are sponsored by Genentech, a unit of Roche. ABT-263 is being co-developed by Genentech and Abbott Laboratories.

For the rest of the story, click on The Cancer Letter Archive at left to read the March 12, 2010 issue (subscription or day pass required).
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tags: NCI|  drug development

NCI Advisors Approve Recompetition Of $132 Million Proteomic Network

From The Cancer Letter, March 12, 2010:

In a hotly debated decision, an NCI advisory group approved the institute’s plan to continue an extramural research program using mass spectrometry to discover biomarkers for cancer.

However, the NCI Board of Scientific Advisors mandated that the concept for the $132.5 million five-year program be rewritten and resubmitted to a subcommittee for final approval.

The project in question is a recompetition of grants for the Clinical Proteomic Technology Assessment for Cancer network. Five research teams were initially funded in 2006 under the first phase of the program to develop and standardize mass spectrometry technologies for biomarker studies. Under the recompetition, NCI would fund six to eight U24 awards and issue contracts for a data coordinating center and the production of biospecimens and reagents.

For the rest of the story, click on The Cancer Letter Archive at left to read the March 12, 2010 issue (subscription or day pass required).


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tags: NCI|  research funding

ACS Prostate Cancer Screening Guideline Urges Doctor-Patient Informed Decision

From The Cancer Letter, March 5, 2010:

The American Cancer Society has updated its prostate cancer screening guideline to emphasize informed decisions by patients within the doctor-patient relationship.

The society abandoned its campaigns for mass screening in 1997, but its guidelines have been widely misunderstood to endorse screening all men at average risk starting at age 50.

Released on March 3, the latest version of the document tries to clear up confusion by stating repeatedly that it does not recommend screening uniformly.

For the rest of the story, click on The Cancer Letter Archive at left to read the March 5, 2010 issue (subscription or day pass required).


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tags: cancer screening

Obama's Virtual Colonoscopy Sets Off Real-World Turf War Of Specialty Groups

From The Cancer Letter, March 5, 2010:

President Barack Obama’s decision to undergo a virtual colonoscopy has triggered an explosion of indignation from two professional societies that represent physicians who perform colorectal cancer screening.

On March 1, the day after the details of Obama’s medical exam were released, the American College of Gastroenterology fired off a letter to the White House objecting to the president’s decision to forego the modality that, the society maintains, represents the gold standard in screening.

An uninitiated observer might have thought that radiologists would rejoice over the President’s decision to go with the CT procedure. They did not. The American College of Radiology issued a statement pointing out that the procedure Obama selected would be unavailable to the elderly receiving Medicare benefits and many people whose commercial insurance doesn’t cover the CT procedure.

The turf war is illustrative of incongruity of guidelines and the role professional societies play in promulgating them, observers say.

For the rest of the story, click on The Cancer Letter Archive at left to read the March 5, 2010, issue (subscription or day pass required).


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tags: White House|  cancer screening

NCI-Frederick Leases Office Building To Move Some Programs Off Army Base

From The Cancer Letter, Feb. 26, 2010:

NCI-Frederick, the federally-funded research and development center for cancer and HIV research located at the Fort Detrick Army base in Frederick, Md., plans to move part of its operations off the base and into an office park at the end of 2011.

SAIC-Frederick Inc., a subsidiary of Science Applications International Corp., the major contractor at NCI-Frederick, has signed a lease on a newly constructed 330,000-square-foot building shell. The government will spend $130 million to outfit the interior for offices and laboratories. The operating budget for the facility will be about $12 million a year.

Craig Reynolds, director of NCI-Frederick, said the move will create the NCI-Frederick Advanced Technology Partnership Initiative, providing space for researchers working at Frederick to form partnerships with private firms to test advanced technologies and conduct translational research.

For the rest of the story, click on The Cancer Letter Archive at left to read the Feb. 26 issue (subscription or day pass required).


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tags: NCI|  drug development

ESA Risk Mitigation Strategy Requires Training, Patient Consent, Documentation

From The Cancer Letter, Feb. 19, 2010:

FDA has approved a “risk evaluation and mitigation strategy” for erythopoiesis-stimulating agents for chemotherapy-related anemia.

The measures, known under the acronym REMS and mandated two years ago by the FDA Oncologic Drugs Advisory Committee, require additional training and certification for healthcare providers as well as distribution of a “medication guide” for patients who may be receiving these agents.

For the rest of the story, click on The Cancer Letter Archive at left to read the Feb. 19 issue (subscription or day pass required).

Also in this issue: FDA’s Office of Oncology Drug Products approved more than 50 new indications for the use of oncology and hematology drugs and biologics between July 2005, when the office began reviewing marketing applications, and the end of 2007, according to a new agency study.

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tags: FDA

Breaking With Tradition, NIH Director Heads Obama’s Search For NCI Director

From The Cancer Letter, Feb. 12, 2010:

In a significant break with tradition, NIH Director Francis Collins is leading the Obama administration’s search for an NCI director, The Cancer Letter has learned.

For nearly three decades after the signing of the 1971 National Cancer Act, a law that gave NCI special authorities and made the institute director a presidential appointee, prominent players in the cancer field formed committees that selected NCI directors.

This tradition was first broken when former President George W. Bush handed NCI to a family friend, the urologist Andrew von Eschenbach, who, upon departing for a job as the head of FDA, picked his successor, John Niederhuber, the current director.

Now, President Barack Obama has not taken the opportunity to reinstate the tradition of delegating selection of his NCI director to a group with even nominal independence, and for the first time, handed control over the selection to the NIH director. This is important because in the past, NIH and NCI have had conflicting priorities, and their directors sometimes clashed over issues big and small.
Collins declined to comment on the search.

“He is involved in the search,” NIH spokesman John Burklow confirmed in an email to The Cancer Letter. “There is no formal search committee.”

Collins is leading what appears to be an ad hoc group that includes Harold Varmus, president of Memorial Sloan-Kettering Cancer Center, and Eric Lander, founding director of the Broad Institute of MIT and Harvard, sources said.

For the rest of the story, click on The Cancer Letter Archive at left to read the Feb. 12 issue (subscription or day pass required).

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tags: NCI|  White House

President Proposes $1 Billion Increase For NIH

From The Cancer Letter, Feb. 5, 2010:

President Barack Obama’s FY2011 budget request includes $32.2 billion for NIH, an increase of $1 billion, or 3.2 percent.

Cancer and autism are listed as “high-priority areas” for the administration. NCI would receive $5.26 billion, an increase of $162.9 million—the largest dollar increase proposed for any of the NIH institutes—over the current budget of $5.1 billion.

Also in this issue:

• AHRQ Draft Report Finds No Benefit For Biomarker Testing In Oncology
  

For the rest of the story, click on The Cancer Letter Archive at left to read the Feb. 15 issue (subscription or day pass required).

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tags: White House|  research funding

Duke In Process To Restart Three Trials Using Microarray Analysis Of Tumors

From The Cancer Letter, Jan. 29, 2010:

Duke University said it is in the process of restarting three clinical trials using microarray analysis of patient tumors to predict their response to chemotherapy.

The university halted the trials to review their scientific underpinnings after a paper in the Annals of Applied Statistics said that the genomic technology developed at Duke and used in the trials incorporated errors and inaccurate calculations and could conceivably put patients at risk (The Cancer Letter, Oct. 2, Oct. 9, Oct. 23, 2009).

In a letter to the editor of The Cancer Letter, Duke officials said that the Institutional Review Board had consulted three directors of cancer centers, who recommended that the patients continue to receive the treatments.

For the rest of the story, click on The Cancer Letter Archive at left to read the Jan. 29 issue (subscription or day pass required).

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tags: clinical trials

I-ELCAP Moves From Weill Cornell To Arizona State

From The Cancer Letter, Jan. 22, 2010:

A controversial program aimed at screening current and former smokers for signs of early-stage lung cancer is in the process of departing from Weill Cornell Medical College.

The research group, called the International Early Lung Cancer Action Program, said it has moved its “coordinating site” to the Arizona State University’s Biodesign Institute in Tempe, and top academic leaders of the group now appear on the web site of Mount Sinai School of Medicine.

I-ELCAP, led by radiologist Claudia Henschke, has been plagued with problems, which included revelations of undisclosed conflicts of interest, receiving funding from a tobacco company, and retractions of key scientific claims about effectiveness of screening for early lung cancer.

Also in this issue:

• Ratain To Lead New Center For Personalized Therapeutics At University of Chicago
  

For the rest of the story, click on The Cancer Letter Archive at left to read the Jan. 15 issue (subscription or day pass required).

The Cancer Letter is no longer offered in a print edition. Former print subscribers: if you haven't already given us your email address, please use the Contact Us link at left.
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tags: cancer screening

Lawsuit Challenges FDA Authority To Regulate Off-Label Promotion

From The Cancer Letter, Jan. 15, 2010:

FDA’s authority to regulate what companies can say about off-label uses of drugs is once again being tested in federal courts.

Allergan Inc., the sponsor of the neurotoxin Botox, has filed a suit that broadly challenges the regulatory agency’s powers in the context of the First Amendment.

Though the issue of off-label promotion is important throughout medicine, it is particularly relevant to oncology, where such use of drugs is widespread. Allergan’s court challenge, filed in the U.S. District Court for the District of Columbia, is taken seriously by legal observers and FDA-watchers familiar with what can happen when the courts apply the constitutional filter to the agency’s regulatory practices.

Also in this issue:

• Harold Varmus plans to leave job as MSKCC president.
  

For the rest of the story, click on The Cancer Letter Archive at left to read the Jan. 15 issue (subscription or day pass required).

The Cancer Letter is no longer offered in a print edition. Former print subscribers: if you haven't already given us your email address, please us the Contact Us link at left.
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tags: FDA|  drug development

In Vote Against Tarceva As Maintenance, ODAC Seeks Stronger Survival Benefit

From The Cancer Letter, Dec. 18, 2009:

In a recommendation that will likely have broad implications for FDA approval of “maintenance” therapies for advanced cancer, the FDA Oncologic Drugs Advisory Committee voted 12-1 against approval of Tarceva (erlotinib) as maintenance in the treatment of non-small cell lung cancer.

For the rest of the story, which examines why Alimta got its NDA in this indication while Tarceva is likely headed for defeat, click on The Cancer Letter Archive at left to read the Dec. 18 issue (subscription or day pass required).

Also in this issue:

• President Obama signs bill giving 2.8 percent increase to NCI.

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tags: FDA|  drug development