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Washington Post - Biden holding cancer summit to pump up support for ‘moonshot’ effort

Vice President Biden will convene a day-long cancer summit in Washington on Wednesday that will be part pep rally, part Ted talk, part wonk-a-thon — all designed to garner support for the Obama administration’s year-long initiative to advance cancer research.

The summit, expected to draw as many as 300 people from academia, industry and advocacy groups to Howard University, is billed as a way to generate new ideas to beat a disease that kills almost 600,000 Americans a year. Dozens of regional summits will take place at the same time.

Bloomberg - Breakthrough Drugs Developed, Reviewed Faster

The FDA's breakthrough therapy designation has led to shorter drug development times and shorter FDA review times, industry experts said April 12 during a Senate briefing.

Enacted in July 2012 as part of the Food and Drug Administration Safety and Innovation Act (Pub. L. No. 112-144), the breakthrough therapy designation expedites the development and review of drugs for serious or life-threatening conditions if the drug has demonstrated substantial improvement on at least one clinically significant endpoint over available therapies.

The Washington Post - He won his own battle against cancer. Biden just picked him to lead a war

Greg Simon was on his way to visit a friend in San Francisco in 2014 when he called his doctor to get the results of a long-overdue physical. Your cholesterol and PSA tests are fine, his doctor said. But, he added, you have leukemia.

The Scientist - The Challenges of Precision

The amount of genetic variation between cancer patients is astounding. Two people diagnosed with cancer in the same organ may, in fact, have two very different diseases. Consequently, we are now in the middle of a transition: we no longer classify cancer based solely on its tissue of origin, but also on the key mutations driving growth and spread of a patient’s tumor.

OncLive - Broader Trial Criteria Would Almost Double Eligibility in Advanced NSCLC

A broader set of clinical trial eligibility criteria proposed by the American Society of Clinical Oncology (ASCO) and Friends of Cancer Research would nearly double the number of patients with advanced non-small cell lung cancer (aNSCLC) available for enrollment, according to findings presented at the 2019 ASCO Annual Meeting.

 

The ASCO Post - 2019 ASCO: Expansion of Clinical Trial Inclusion Criteria in Patients With Advanced NSCLC

A study that examined 10,500 health records of patients with advanced non–small cell lung cancer from ASCO’s CancerLinQ database found that the use of expanded clinical trial inclusion criteria—as proposed by ASCO and Friends of Cancer Research in 2017—would nearly double the percentage of patients eligible to enroll in clinical trials—from 52.3% to 98.5%. The expanded clinical trial eligibility criteria would allow patients with advanced NSCLC and brain metastases, previous or concurrent cancers, and limited kidney function to enroll in clinical trials.

Genetic Engineering & Biotech News - Will Testing for Tumor Mutational Burden Bring the Same Challenges as Testing for PD-L1?

While PD-L1 testing has become commonplace with immuno-oncology treatment, the multitude of available antibodies, cut-offs, and scoring algorithms makes this biomarker anything but uniform and consistent. Developments over this past year in the diagnostic market hint that tumor mutational burden (TMB) may face the same variability challenges as PD-L1: the results from one TMB test may not be interchangeable with the next.

 

GenomeWeb - Christiana Care Preparing IND for CRISPR-Based Lung Cancer Therapy

Christiana Care Health System's Gene Editing Institute is preparing to file an investigational new drug application (IND) with the US Food and Drug Administration for a clinical trial protocol that will use CRISPR genome editing to improve the efficacy of chemotherapy for KRAS-positive non-small-cell lung cancer (NSCLC) patients.

 

The ASCO Post - ASCO Announces New Task Force to Address Rural Cancer Care Gap

ASCO recently announced a new task force aimed at reducing disparities and improving outcomes for patients and survivors of cancer who live in rural communities. The new Rural Cancer Care Task Force will identify opportunities to close the rural cancer care gap and implement strategies to improve rural cancer care in the United States.

 

Pink Sheet - Cell Therapies: US FDA Asked To Clarify Development Standards For Early-Phase Trials

Executive Summary

Academic institutions confused about agency standards are overly cautious in requiring early-phase studies be conducted under full GMPs, experts say; CBER Director Marks highlights regulatory flexibility but cautions that formal written guidance could be misused by those in stem cell industry.

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