Biologics

Jazz Biliary Tract Cancer BLA Approved

FDA has granted Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii), a bispecific HER2-directed antibody for previously treated, unresectable or metastatic HER2-positive biliary tract cancer.

Approval is based on data from the HERIZON-BTC-01 (NCT04466891) open-label, single-arm trial in 62 patients, according to an agency release. The major efficacy outcome measures were objective response rate (52%) and duration of response (14.9 months), it says.

Regarding safety, FDA says the prescribing information requires a boxed warning for embryo-fetal toxicity. “The most common adverse reactions reported in at least 20% of patients who received zanidatamab-hrii were diarrhea, infusion-related reactions, abdominal pain, and fatigue,” it adds.

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