Drugs

Janssen Files Imbruvica sNDA for Lymphoma

Janssen Research & Development has submitted a supplemental NDA for Imbruvica (ibrutinib) for treating patients with marginal zone lymphoma (MZL) who require systemic therapy. The filing is based on data from an open-label Phase 2 trial called PCYC-1121 that evaluated the therapy in MZL patients who have received at least one prior therapy. The drug is jointly developed and commercialized by Janssen and Pharmacyclics, an AbbVie company.

The PCYC-1121 trial enrolled 63 patients who were given ibrutinib 560mg orally, once daily until progression or unacceptable toxicity. The primary endpoint of the study was overall response rate as assessed by an independent review committee. Key secondary endpoints included duration of response and overall response rate. The data have been submitted for publication in a peer-reviewed journal and presentation at an upcoming medical conference, Janssen says.

Imbruvica is currently approved to treat patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, including patients with 17p deletion, patients with mantle cell lymphoma who have received at least one prior therapy and patients with Waldenström’s macroglobulinemia.

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