Drugs

FDA Steps Up Monitoring of PD-1/PD-L1 Inhibitors: Woodcock

FDA is stepping up its safety surveillance on PD-1/PD-L1 inhibitors after an investigational clinical trial involving Merck’s Keytruda (pembrolizumab) in combination with other therapies in multiple myeloma patients “found an excess of deaths for patients receiving Keytruda when combined with these other drugs,” CDER director Janet Woodcock says in a safety alert. The agency, she says, is “actively examining the data from the Keytruda trials and working directly with Merck to better understand the true cause of the safety concerns. In addition, the agency is working with sponsors of other similar cancer drugs, known as PD-1/PD-L1 inhibitors, to examine other trials in which these drugs are being studied in combination with other drugs, known as immunomodulatory agents, and in which they’re being studied in combination with other classes of drugs in hematologic malignancies.”

In June and based on a data monitoring committee recommendation, Merck paused new enrollment on KEYNOTE-183 and KEYNOTE-185, two studies exploring Keytruda’s treatment in combination with other therapies in multiple myeloma (see earlier story). FDA has since ordered a clinical hold on the studies as part of its investigation.

KEYNOTE-183 is a Phase 3 study comparing pomalidomide and low-dose dexamethasone with Keytruda to pomalidomide and low-dose dexamethasone alone in patients with refractory or relapsed and refractory multiple myeloma who have undergone at least two lines of prior treatment. KEYNOTE-185 is a Phase 3 study comparing lenalidomide and low-dose dexamethasone with Keytruda to lenalidomide and low-dose dexamethasone alone in patients with newly diagnosed and treatment-naïve multiple myeloma who are ineligible for autologous stem cell transplant.

Providing more details of the study concerns, Woodcock notes Keytruda is not approved for treating multiple myeloma and should not be given to patients in combination with any immunomodulatory agents, including Revlimid (lenalidomide) and Pomalyst (pomalidomide), for treating the disease. Keytruda is currently indicated for treating patients with unresectable or metastatic melanoma at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity. It is also approved for treating lung cancer and head and neck cancer.

Notwithstanding the new safety concerns, Woodcock says the agency “still believes the benefits of taking these drugs for their approved uses and as indicated in the labels continue to outweigh their risks.”

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