Ahead of a Capitol Hill hearing this week on the role of the FDA in the regulation of laboratory-developed tests, the federal agency published a report of 20 case studies that illustrated the possible harms presented to patients when laboratories do not comply with FDA requirements.
One might surmise that by the time FDA asks an advisory committee to vet an application, the questions would deal primarily with clinical utility.
THE PAN-MASS CHALLENGE announced a gift of $45 million to support adult and pediatric patient care and cancer research at Dana-Farber Cancer Institute, bringing the PMC's 36-year fundraising total to a half-billion dollars raised since the organization's inception in 1980.
MD ANDERSON CANCER CENTER and Codiak BioSciences formed license and sponsored research agreements. Codiak also recently completed the first portion of $80+ million Series A and B financing.
THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY published 11 principles and detailed guidance to the Centers for Medicare & Medicaid Services as it implements the Merit-based Incentive Payment System and Alternative Payment Models under the Medicare Access and CHIP Reauthorization on Act of 2015, which replaced the Sustainable Growth Rate formula.
FDA granted accelerated approval to Tagrisso (osimertinib) tablets for the treatment of patients with metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer, as detected by an FDA-approved test, who have progressed on or after EGFR tyrosine kinase inhibitor therapy.
NCI named the inaugural 43 recipients of its Outstanding Investigator Awards.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies last month. For further information, contact the principal investigator listed.
A multicomponent outreach program increased completion of the three-dose human papillomavirus vaccination series that reduces the risk of cervical cancer, according to a joint study by UT Southwestern Medical Center and Parkland Health & Hospital System.
Telotristat etiprate showed clinical benefit in treating carcinoid syndrome in cancer patients not adequately controlled by long-acting somatostatin analog therapy, the current standard of care, according to data from the phase III TELESTAR study.
