Drugs

Darzalex OK’d for Multiple Myeloma Combo Therapy

FDA has approved a Janssen Biotech supplemental BLA for the use of Darzalex (daratumumab) in combination with Amgen’s Kyprolis (carfilzomib) and dexamethasone for relapsed/refractory multiple myeloma in those who have received one to three previous therapies. Approval was based on data from the Phase 3 CANDOR study that evaluated 466 relapsed or refractory patients with multiple myeloma at 120 global sites. Patients were treated until disease progression, and the primary endpoint was progression-free survival, according to the company. Key secondary endpoints were overall response rate, minimal residual disease and overall survival. CANDOR is an Amgen-sponsored study and is co-funded by Janssen.

In the U.S., Darzalex is approved as a monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI ) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent. In 2016, it was approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for treating patients with multiple myeloma who have received at least one prior therapy. In 2017, it was approved in combination with pomalidomide and dexamethasone for treating patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a PI.

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