Drugs

Janssen NDA for Urothelial Cancer Drug

Janssen Pharmaceutical has submitted an NDA seeking approval of erdafitinib for treating patients with locally advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational oral pan-FGFR inhibitor that received breakthrough therapy designation from the agency 3/18.

Janssen says its submission is based on data from the BLC2001 (NCT02365597) Phase 2 clinical trial with a primary endpoint of the percentage of participants with an objective response. There was a 40% confirmed overall response rate (3% complete response, 37% partial response), a median progression-free survival of 5.5 months and median overall survival of 13.8 months, according to results presented at a medical conference earlier this year. Janssen says that in patients who experienced Grade 3 adverse events (AEs), the most common were stomatitis (9%), hand-foot syndrome (5%) and diarrhea (4%). Seven patients discontinued due to treatment-related AEs.

FGFRs are a family of receptor tyrosine kinases, which can be activated by genetic alterations in a variety of tumor types, and these alterations may lead to increased tumor cell growth and survival, the company says. A companion diagnostic to identify patients with FGFR alterations is also under development, Janssen says.

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

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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