Drugs

FDA OKs Keytruda Plus Inlyta for Kidney Cancer

FDA has approved a Merck supplemental NDA for use of its Keytruda (pembrolizumab) plus axitinib (Pfizer’s Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on data from the KEYNOTE‑426 (NCT02853331), an 861-patient trial in those who had not received systemic therapy for advanced RCC. The trial demonstrated a statistically significant improvement in overall survival (OS) in a pre-specified interim analysis for patients on the pembrolizumab plus axitinib compared with those on an active comparator.

An FDA release says that with “deaths reported in 18% of patients, the median OS was not reached in either arm.” The 12-month OS rate was 90% in the pembrolizumab plus axitinib arm and 78% for those treated with sunitinib (Pfizer’s Sutent). The trial also demonstrated a progression-free survival (PFS) improvement for patients receiving pembrolizumab plus axitinib. “Median PFS was 15.1 and 11.1 months for those receiving pembrolizumab plus axitinib vs. sunitinib, respectively,” it 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