Drugs

FDA Looking for Ways to Help Cancer Therapies Evolve Safely

CBER director Peter Marks says FDA is looking for ways to encourage cancer therapies to evolve quickly with enough information coming to the agency that it can be sure that patients are safe while still not holding back development. Marks spoke on a panel at a virtual meeting sponsored by Friends of Cancer Research (FoCR) on “Shaping the Future of Emerging Immunotherapies and Cell Therapies.” He also said FDA wants to find ways to allow sponsors to make beneficial product changes as therapies evolve. The agency is also looking at how best to understand ways to clinically develop therapies, he said.

At the beginning of his presentation, Marks cited statistics showing the increase in CAR (chimeric antigen receptor) T-cell therapies from 2015 (20 INDs) to 2020 (58 INDs). He spoke of the maturation of the manufacturing process and said that each year brings new technologies into the CAR T-cell world.

In preparation for the meeting, FoCR released a white paper, “Harmonizing the Definition and Reporting of Cytokine Release Syndrome in Immuno-Oncology Trials” that established a standard approach for defining and capturing cytokine release syndrome.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome