This episode focuses on the strategies for assessing non-small cell lung cancer (NSCLC) therapies that have received FDA ...

Nearly 70% of cancer drugs granted FDA accelerated approval between 2011 and 2020 required safety updates within 4 years.“Postmarketing safety actions are common,” Maryam Mooghali, MD, MSc, internal ...

The U.S. Food and Drug Administration's accelerated approval program is meant to give patients early access to promising drugs. But how often do these drugs actually improve or extend patients' lives?

Minimal residual disease (MRD) refers to the small number of myeloma cells that may remain after treatment and are not detectable using conventional response criteria. In multiple myeloma, MRD ...

In patients naïve to HER2-targeted therapy, the objective response rate was 71% with a median duration of response of 9.2 months. The Food and Drug Administration (FDA) has granted accelerated ...

Early access to new cancer drugs, granted accelerated approval by the U.S. Food and Drug Administration (FDA), has provided mixed benefits for patients while costing Medicare billions of dollars, ...

In an interview, Jackson Peter Kim, MD, clinical assistant professor in the Division of Nephrology at Stanford Health Care, described his initial reaction as one of optimism. In a field that “was so ...