Posts Tagged ‘cancer therapies’

Through the Murky Slog: Part II—A New Light for Cancer Therapies?

November 9th, 2011
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Last week, we discussed new drug approvals that reflected a paradigm shift for cancer drug development and for treatment of people living with cancer. Finally, we are starting to see a matchup of specific diagnostics with targeted biotherapeutics to address (effectively, we hope) targeted treatments for smaller groups of cancer patients.
Just recently, the American Society for Clinical Oncology (ASCO) urged the use of new biological knowledge to develop treatments faster, design more targeted clinical trials, and use information technology to integrate once-separate translational and clinical research. ASCO even says that targeted therapies can improve clinical trial responses from 8 to 30 percent. Also, just recently, the FDA gave itself a pat on the back as it highlighted its recent innovative drug approvals, with targeted cancer therapies included among those on the list.
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Are We at the End of a Long, Murky Slog in Cancer Treatment?

November 4th, 2011
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For many years, a lot of people (including us) have called for a new way to look at, diagnose, and treat cancer. This means changing everything – from how we classify cancer to research strategies to treatment regimens. It’s been a long slog, through murky data and lots of failures, but now we’re finally seeing targeted treatments, matched with diagnoses to select the right niche of patients. Best of all, there is strong evidence to suggest that those treatments may work very well in those patient cohorts.
These are unlike most current cancer therapies, which are marked by “broad brush” descriptions (“a breast cancer drug”) and expensive price tags that can wipe out savings, burden insurance companies, and may have little benefit. But the FDA has just approved a series of treatments (albeit for rarer and later-stage cancers) that come with companion diagnostics to make sure the patient is the right one (i.e., has the right biomarker profile) for that drug. Identification of these patients prior to treatment means that while the treatments are still very costly, they stand a much better chance of actually working.
Just recently, the FDA approved (under its fast-track NDA approval system):
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