Drugs

Two Imbruvica Accelerated Approvals Withdrawn

Janssen Biotech and Pharmacyclics have announced their decision to voluntarily withdraw two accelerated approval indications for Imbruvica (ibrutinib) — treating patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, and treating patients with marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy. The withdrawal decisions were made after the companies consulted with FDA, who told the company that required confirmatory studies could not support conversion to full approval.

“The Phase 3 SHINE study met its primary endpoint and demonstrated a significant progression-free survival advantage in patients with previously untreated MCL but did not show an overall survival advantage,” the companies say. “The addition of Imbruvica to chemoimmunotherapy was associated with increased adverse reactions compared to the placebo-controlled arm.” Meanwhile, in the Phase 3 SELENE study, the therapy did not meet its primary endpoint of progression-free survival in patients with MZL.

The withdrawal decisions do not affect other approved indications for Imbruvica, according to the companies. The therapy was first approved 11/2013, and today it is indicated for adult patients in four disease areas, including three hematologic cancers. These include indications to treat adults with chronic lymphocytic leukemia/small lymphocytic lymphoma; adults with Waldenström’s macroglobulinemia; and adult and pediatric patients aged one year and older with previously treated chronic graft-versus-host disease.

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