Preparing for the First Wave: Biosimilars at ASCO 2018

Posted by Max Kuehn on Sep 5, 2018 8:00:00 AM

As always, clinical innovation dominated the conversation at ASCO 2018, but many attendees also made time to attend sessions on value and financial burden, where biosimilars were a frequent topic. With more than 40 biosimilars already approved in the EU, and rituximab, trastuzumab and bevacizumab biosimilars approaching launch in the U.S., biosimilars will play a major role in the future oncology landscape. 


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CAR-T Therapies: Improving on Today’s Reality and Planning for Tomorrow’s Innovation

Posted by Sharon Karlsberg on Jul 5, 2018 8:00:00 AM

Katie Blodgett and Robert Rovner co-authored this post with Sharon Karlsberg. 

Adoptive cell immunotherapy got top billing at this year’s American Society of Clinical Oncology (ASCO) meeting with its designation as the 2018 clinical cancer “Advance of the Year,” and for good reason. The first generation of chimeric antigen receptor T-cell (CAR-T) therapies, set in motion with the late 2017 approvals of Kymriah (Novartis) and Yescarta (Kite, a Gilead company), are among the most anticipated cancer breakthroughs to date.


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Using Novel Endpoints to Transform Oncology Clinical Trials

Posted by Malik Kaman on Jun 28, 2018 8:00:00 AM

Joshua Hattem and Matt Furlow co-authored this post with Malik Kaman.

To match the rapid changes occurring in cancer therapy development, oncology clinical trials are making a few changes of their own. As contemporary clinical trials break with tradition by infusing new, or different, outcome measures to better assess clinical efficacy, the results are encouraging: Single-arm phase I/II trials are gaining accelerated approvals using overall response rate (ORR) and duration of response (DoR) as proxies for survival and 72% of the oncology treatments reviewed by the FDA since 2006 gained approval based on response rate and progression-free survival endpoints.


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Precision Medicine Comes Into View With the Use of Next-Generation Sequencing

Posted by Jon Roffman on Jun 27, 2018 8:00:00 AM

Marie Yurkovich and Olivia Tang-Kong co-authored this post with Jon Roffman.

Precision medicine in cancer care has been anticipated and talked about for years. The ability to classify a patient based on her tumor’s molecular changes and then treat her with the right targeted therapy is a concept that gives hope to the many men, women and children diagnosed with cancer. Given recent advancements, there’s good reason for this hope.


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