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Clinical trial delivers results in leukemia patients
By Dross at 2012-11-30 21:21
Clinical trial delivers results in leukemia patients

Two researchers from the Huntsman Cancer Institute have published results for a recent clinical trial using the drug ponatinib for the treatment of chronic myelogenous leukemia in patients that were refractory to Gleevec and other standard treatments for Philadelphia chromosome positive hematological neoplasms.

Conducted at five cancer centers, this phase one trial demonstrated that ponatinib was highly active in patients with CML and Ph++ ALL who were resistant to approved tyrosine kinase inhibitors.

 "Ponatinib is arguably the most potent and broadest BCR-ABL1 available thus far, covering even the T315I mutant, which is completely resistant against all approved TKIs", says Deininger, a senior author on the study who leads an ongoing ponatinib trial at Huntsman Cancer Institute. "The results of this study as well as preliminary data from a larger phase 2 trial show that ponatinib has remarkable activity in patients with resistant CML and Ph+ ALL, suggesting that this new TKI will expand our therapeutic armamentarium very significantly. It is a poster child for personalized cancer therapy."



6 comments | 2602 reads

by gdpawel on Fri, 2012-11-30 23:03
In another stumbling block for personalized medicine, MolecularMD has chosen to pull its premarketing approval application to the FDA for its BCR-ABL T315I Mutation Test. The company made this announcement yesterday with Ariad Pharmaceuticals. The test was meant to be a companion diagnostic to be used with Ariad’s BCR-ABL inhibitor, ponatinib, which is under FDA review for the treatment of resistant or intolerant chronic myeloid leukemia and Philadelphia-chromosome positive acute lymphocytic leukemia. But the FDA’s Center for Devices and Radiological Health told MolecularMD recently that the test is not considered a companion diagnostic for ponatinib. FDA guidance states that for a test to be considered as a companion diagnostic test, it must provide information that is essential for the safe and effective use of a therapeutic product.

According to Joshua P. Cohen, Ph.D., Senior Research Fellow, Tufts Center for the Study of Drug Development says while the withdrawal is a minor blow, it will not have major repercussions to the development of personalized medicine.

“Personalized medicine will progress the same way a toddler learns to walk,” he says. “The important thing is companies are collaborating at earlier stages in the drug development process to develop therapeutics and tests in tandem. In this respect, they are following FDA guidance on personalized medicine and co-development of test and therapeutic. Ultimately, the more co-developed product combinations companies launch the better off patients will be. Moreover, it is a win-win situation in that other stakeholders, such as payers, providers, and the pharmaceutical industry stand to benefit as well.”

In July 2011, Dr. Cohen released a study titled “Lack of clinically useful diagnostics hinder growth in personalized medicines.” Among the study findings was the fact that less than 1 percent of currently marketed drugs in U.S. have a companion diagnostic. Lack of clinical usefulness of many companion diagnostics has led payers to deny or restrict reimbursement of tests.

Just 10 percent of currently marketed drugs have pharmacogenomic info on labeling. Of eight drugs reviewed, AstraZeneca’s Iressa presents the highest barriers to developers and payers, followed by Tarceva, Erbitux, and Camptosar. Two widely cited reasons by payers and developers were a lack of evidence supporting efficacy of companion diagnostics and the cost of companion diagnostics. Patients also noted a lack of insurance coverage for companion tests.

“The input provided by the Agency to MolecularMD regarding its T315I mutation test indicates that the T315I mutation test is no longer required as a companion diagnostic test to identify patients with the BCR-ABL T315I mutation who may be treated with ponatinib,” said Harvey J. Berger, M.D. chairman and chief executive officer of Ariad. “We look forward to continuing our longstanding collaboration with MolecularMD, the world leader in BCR-ABL testing, in clinical trials of ponatinib in patients with CML.”

“We are pleased to see ponatinib moving forward in its U.S. regulatory review and look forward to continuing our close involvement with its ongoing and future clinical development as a premier companion diagnostic partner ,” stated Dan Snyder, President, chief operation officer of MolecularMD.

Mia Burns, Associate Editor, Pharmalive.com

by gdpawel on Fri, 2012-11-30 23:06
Back in 2010, a report from the Agency for Healthcare Research and Quality (AHRQ) suggested that some mutations of the BCR-ABL gene make the cancer resistant to Gleevec (imatinib), which is designed to block the action of the hyperactive tyrosine kinase receptors in patients with CML.

But they say not to look to any tests currently on the market to determine what they are. The review of 31 studies found that the presence of any BCR-ABL mutation does not appear to predict differential response to treatment in CML patients treated with Gleevec (imatinib), Sprycel (dasatinib) or Nilotinib based regimens.

Indeed, the report said there is "no evidence that presence of any BCR-ABL mutation can differentiate reponse to tyrosine kinase inhibitor therapies." "It is possible that pharmacogenetic (how our inherited genes affect the way we respond to drugs) testing and the subsequent use of targeted therapies will add cost without producing clinically meaningful improvement in patients outcomes," the report said.

There are some challenges in the development and practical use of pharmacogenomics. Many doctors now do not widely practice pharmacogenomics when treating patients since the field is still new.

Pharmacogenetic testing is also expensive, and insurance plans may not cover the costs of available tests. Researchers are working to develop more efficient and less expensive testing methods.

Although federal legislation has been passed that makes it illegal for companies and insurers to discriminate against people based on their genetic information, some ethical, legal, and privacy issues remain unresolved, which may affect the continued development of pharmacogenomics.

[url]http://www.ahrq.gov/

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