Drugs

FDA OKs Janssen’s Balversa

FDA has approved a Janssen Biotech NDA for Balversa (erdafitinib) for treating adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test. The drug is indicated for mUC patients whose disease has progressed on or after at least one line of prior systemic therapy. “Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy,” an FDA notice says. “This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.”

Approval was based on efficacy from the Study BLC3001 Cohort 1 and patients were randomized 1:1 to receive erdafitinib or investigator’s choice of chemotherapy (docetaxel or vinflunine), according to FDA. Statistically significant improvements in overall survival (OS), progression-free survival, and objective response rate were demonstrated for erdafitinib compared with chemotherapy, it says. “Median OS was 12.1 months (95% CI: 10.3, 16.4) for patients who received erdafitinib and 7.8 months (95% CI: 6.5, 11.1) for those who received chemotherapy (hazard ratio [HR] 0.64 [95% CI: 0.47, 0.88]; p-value=0.0050). Median PFS was 5.6 months (95% CI: 4.4, 5.7) for patients who received erdafitinib and 2.7 months (95% CI: 1.8, 3.7) for those who received chemotherapy (HR 0.58 [95% CI: 0.44, 0.78]; p-value=0.0002). Confirmed ORR was 35.3% (95% CI: 27.3, 43.9) for those who received erdafitinib and 8.5% (95% CI: 4.3, 14.6) for those who received chemotherapy (p-value<0.001).”

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