Drugs

Few Cancer Drugs to Work with Radiation: FDA Staff

Staffers in the CDER Office of Hematology and Oncology Products say that of more than 250 new drug and biologic applications approved by the office since 2006, only one was approved for use with radiation. Writing in an International Journal of Radiation Oncology commentary (subscription or purchase required), the staffers say that despite the fact that radiation therapy continues to be a mainstay of both curative and palliative cancer therapies, there has been a persistent lack of drug development using potential synergies between radiation and targeted systemic therapies.

The authors say the reasons for the discrepancy are complex and multifactorial, including limited regulatory precedent for drugs developed specifically for use with radiation therapy, and perceived challenges in trial design with radiation.

The article looks at the existing regulatory framework in which cancer drugs may be developed in combination with radiation therapy and describes the mechanisms in place for sponsors to obtain feedback from FDA during drug development.

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