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STAT - New study points to best way to assess which cancer patients immunotherapy will help

Experiments involving just a few patients have hinted at it, and research on one type of tumor at a time has supported it, but a large study has now delivered the strongest evidence yet about how to identify cancer patients who are likely to benefit from a particular form of immunotherapy: count.


Healio - Modernized trial eligibility criteria aim to remove comorbidities as a barrier to enrollment

Patients with cancer and comorbidities are routinely left out of clinical trial discussions, offers and participation, according to results of a study published in JAMA Oncology.


At least 60% of trial eligibility exclusions are related to patient comorbidities or performance status, according to study background.


Those statistics could start to change because of the implementation of new eligibility guidelines for clinical trials, due in part to this and other studies.


Fred Hutch News Service

How do you make cancer clinical trials available to more patients?


A new study published today in JAMA Oncology and led by Dr. Joseph Unger at Fred Hutchinson Cancer Research Center offers a tantalizing solution: loosen up the strict eligibility criteria. 


Pink Sheet - Breakthrough Denial Doesn't Mean US FDA Won't Bring Full Resources To Application

Executive Summary

Agency staff discuss how they offer early development advice to sponsors before a breakthrough decision is made and reassure them if the status is denied.


Sponsors may desire breakthrough status because of the perks that come with it, but US FDA officials said promising non-breakthrough products also could receive a lot of attention to speed them to market.


Billy Dunn, director of the Office of Neurology Products, said his staff does not approach an application differently whether or not it obtains breakthrough status.


Pink Sheet - 340B Payment Cut Overturned By US Federal Court; What Comes Next?

Executive Summary

Siding with coalition of hospitals, judge ruled that HHS lacked authority to cut Medicare reimbursement for drugs purchased at 340B prices. That should change the dynamics of the 340B reform debate heading into 2019 – but don’t expect the Trump Administration to back down on its push to rein in what it sees as abuses of the discount.


Pink Sheet - External Control Arms: Better Than Single-Arm Studies But No Replacement For Randomization

Executive Summary

Synthetic control group derived from historical clinical trial data could augment smaller randomized trials and yield better information than single-arm studies, but this approach should not be viewed as a substitute for randomized trials where feasible, US FDA officials said at a Friends of Cancer Research meeting.


Regulatory Focus - FDA Names New No. 2 to Replace Retiring Sherman

The US Food and Drug Administration (FDA) announced Monday that Dr. Amy Abernethy will replace Rachel Sherman as Principal Deputy commissioner of Food and Drugs – the highest position at the agency that is not a political appointee.

Bloomberg - Roche Subsidiary Official to Take No. 2 Role at FDA

One of the leading voices in using health data to advance targeted treatments known as precision medicine has been tapped for the second-highest post at the FDA.


Amy Abernethy, chief medical officer for Flatiron Health, will join the Food and Drug Administration as its principal deputy commissioner early next year, FDA Commissioner Scott Gottlieb announced Dec. 17. She will replace Rachel Sherman, a longtime FDA staffer who is retiring in January.


Pink Sheet - HHS Senior Advisor O’Brien Emerges As Azar’s Lead On Drug Pricing In 2019

Executive Summary

O’Brien assumes role from his late colleague and friend Dan Best as HHS closes out administrative items in the blueprint.


The Trump Administration appears to be ramping up towards some kind of action on drug pricing early in the New Year.


Over the last two weeks, HHS Secretary Alex Azar has been posting regular pictures of meetings with a variety of stakeholders on the issue of drug prices.


Pink Sheet - US FDA Taps Abernethy As Principal Deputy Commissioner; Health IT Exec Brings “Real-World” Expertise

Executive Summary

Abernethy comes to FDA from Flatiron Health, which develops oncology-specific electronic health record software and real-world evidence for cancer research. She succeeds FDA veteran Rachel Sherman, who will retire from the agency in January.