Has Precision Medicine Become Mainstream in Oncology?

Posted by Pavankumar Anne on Jun 28, 2019 8:00:00 AM

The promise of precision medicine—tailoring treatments to genetic changes in each cancer patient—is very exciting. Advances in science and genomic testing have helped speed up the pace of precision medicine and brought several innovative targeted therapies and immunotherapies to market already. Precision medicine was the theme at last year’s American Society of Clinical Oncology (ASCO) annual meeting, with more than 500 abstracts involving genomic testing. It’s safe to say that precision medicine has become a buzzy topic. However, at this year’s ASCO event, we continued to hear that there are significant challenges to the widespread adoption of precision medicine. What will it take to bring the promise of precision medicine to more patients and embed it in routine care?


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Pedal to the Metal: Assessing the FDA’s Real-Time Oncology Review Program

Posted by Matt Furlow on Apr 24, 2019 8:00:00 AM

Sharon Karlsberg and Manna Fujiu co-authored this post with Matt Furlow.

The FDA review process for oncology therapeutics is necessarily rigorous, but during that process cancer patients may be waiting to access new therapies—a matter of life or death in some cases. The FDA has been attempting to accelerate time to approval for oncology therapeutics for the past several years with accelerated approval, priority review, breakthrough designation and other programs and designations (table 1). Recently, the FDA’s Oncology Center of Excellence launched a pilot program for oncology therapeutics called Real-Time Oncology Review (RTOR). Under this program, manufacturers can submit analyses of their clinical data to the FDA as they become available but before a formal supplemental new drug application or supplemental biologics license application is submitted. After submission, the drug can potentially be approved in a matter of weeks or even days.


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Getting a Read on the EU’s Biosimilar Uptake Across Therapeutic Areas

Posted by Christina Corridon on May 31, 2018 8:00:00 AM

Laura Nielsen co-authored this blog post with Christina Corridon. 

Since the first EU biosimilar approval for Sandoz’s Omnitrope 12 years ago, the European biosimilar market has been difficult to predict. The dynamic policy and regulatory environment, differing levels of payer control, and variability in go-to-market approaches and manufacturing necessitate a bit of guesswork when it comes to predicting how a given biosimilar will perform. 


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A Gut Check on the Role of Microbiome in Cancer

Posted by Pranav Srivastava on Jul 26, 2017 11:16:51 AM

Matt Furlow co-authored this post with Pranav Srivastava.

In the novel A Wind in the Door by Madeleine L’Engle, the main character’s younger brother gets sick when fictional symbiotic entities within his mitochondria called farandolae fail to work together to prevent illness. My co-author and I were reminded of that story as we looked for parallels for the symbiotic nature of gut flora and the notion that the gut microbiome can have significant implications on health—a promising area of research that should be on the radar of oncology companies looking to expand their portfolios.


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