‘Me Too’ or Breakthrough? Exploring the Oncology Cell Therapy Pipeline

Posted by Katie Blodgett on Jun 26, 2019 8:00:00 AM

Last year, the American Society of Clinical Oncology (ASCO) designated adoptive cell immunotherapy the 2018 clinical cancer “advance of the year” following the 2017 FDA approvals of Kymriah (Novartis) and Yescarta (Kite, a Gilead company). In the year since, we have seen some incremental, notable approvals in the cell and gene therapy space, but we have yet to see additional cell therapy approvals in oncology. However, like a duck sailing smoothly across the water, the relative inactivity above the surface conceals a flurry of development activity taking place below the surface in the oncology pipeline.


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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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DTC Biomarker Testing: Please Read the Fine Print

Posted by David Kriesman on May 24, 2018 11:17:42 AM

Pavankumar Anne, Sankalp Sethi and Matt Furlow co-authored this post with David Kriesman.

In oncology, we’re accustomed to “firsts” in the headlines—new discoveries, novel treatments and scientific breakthroughs offering hope to patients. Most newsworthy updates relate to emerging therapies, but on March 6, we saw a first in oncology diagnostic testing that has started making waves.


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Five Observations From Successful Oncology ‘First Launches’

Posted by Ben Hohn on Aug 14, 2017 10:29:32 AM

Nicholas Martinez and Cody Powers co-wrote this blog post with Ben Hohn.

The stakes are high when preparing to launch a new drug, but for a biopharmaceutical company staring down its first-ever oncology launch, the stakes are even higher. Drug launches in the oncology space have grown increasingly competitive and occur more frequently than in any other therapeutic category. And of the 202 novel drugs approved by the FDA from 2011 to 2016, five were oncology drugs launched in the U.S. by publicly traded newcomers—so-called “first launches.”  


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Accelerating Real-World Evidence to Advance the Trial Landscape

Posted by Maria Whitman on Jul 19, 2017 9:42:04 AM

Mimi Traylor-Knowles co-wrote this blog post with Maria Whitman.

At the 2017 Annual Society of Clinical Oncology Annual Meeting (ASCO), Dr. Sean Khozin, senior medical officer at the FDA, opened his Saturday session with some trivia: When was the first controlled clinical trial? The answer, which surprised many of my fellow attendees, was 1747, when James Lind held a trial to determine if citrus juice would help control the symptoms of scurvy. Dr. Khozin then showed a timeline to demonstrate the history of controlled clinical trials. He concluded his session with a single but poignant visual: a flat line stretching more than 250 years from then until now. As the world has made historic progress in innovation—from steam locomotives to a man on the moon to the internet and all that we have today—controlled clinical trials have remained largely the same. 


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