Drugs

BMS Reports Opdivo Trial Misses Primary Endpoint

Bristol-Myers Squibb (BMS) has reported disappointing data from its CheckMate-026, a trial investigating the use of Opdivo (nivolumab) as monotherapy in advanced non-small cell lung cancer (NSCLC). The trial did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced NSCLC whose tumors expressed PD-L1 at ≥ 5%, the company says.

“While we are disappointed CheckMate-026 did not meet its primary endpoint in this broad patient population,” BMS says, “we remain committed to improving patient outcomes through our comprehensive development program, including the ongoing Phase 3 CheckMate-227 study exploring the potential of the combination of Opdivo plus Yervoy for PD-L1 positive patients, and Opdivo plus Yervoy, or Opdivo plus chemotherapy in PD-L1 negative patients.”

In CheckMate-026, the trial randomized 541 patients to receive either Opdivo 3 mg/kg intravenously every two weeks or investigator’s choice chemotherapy in squamous patients (gemcitabine with cisplatin/gemcitabine with carboplatin/paclitaxel with carboplatin) and non-squamous patients (pemetrexed with cisplatin/pemetrexed with carboplatin) until disease progression, unacceptable toxicity, or completing six cycles.

Opdivo was approved 11/2015 for use in previously untreated patients with BRAF V600 wild-type unresectable or metastatic melanoma. It has since obtained expanded indications, including treating metastatic non-small cell lung cancer with progression on or after platinum-based chemotherapy, advanced renal cell carcinoma who have received prior anti-angiogenic therapy, and Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post- transplantation brentuximab vedotin.

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