Drugs

Merck’s Keytruda Approved for Esophagus Tumors

FDA has approved Merck’s Keytruda (pembrolizumab) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (determined by an FDA-approved test) with disease progression after one or more prior lines of systemic therapy. Approval was based on data from two clinical trials, KEYNOTE‑181 (NCT02564263) and KEYNOTE‑180 (NCT02559687).

KEYNOTE-181 was a randomized, open-label, active-controlled trial that enrolled 628 patients. The primary efficacy outcome measure was overall survival (OS) in patients with ESCC, patients with tumors expressing PD-L1, and all randomized patients. Median OS was 10.3 months and 6.7 months in the pembrolizumab and control arms, respectively, according to an FDA release.

KEYNOTE‑180 was a single arm, open-label trial that enrolled 121 patients with locally advanced or metastatic esophageal cancer who progressed on or after at least two prior systemic treatments for advanced disease. In the 35 patients with ESCC expressing PD-L1, the overall response rate was 20% and response durations ranged from 4.2 to 25-plus months, with 71% (five patients) having responses of six months or longer and 57% (three patients) having responses of 12 months or longer, FDA 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