FDA Policy/General

FDA OKs Traditional Approval for Genentech’s Polivy

FDA has granted traditional approval to Genentech’s Polivy (polatuzumab vedotin-piiq) for combination use with Rituxan (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for treating certain adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL). Previously the drug was available under accelerated approval in combination with bendamustine and Rituxan for relapsed or refractory DLBCL after at least two prior therapies.

DLBCL is described by Genentech as an aggressive and difficult to treat form of non-Hodgkin’s lymphoma. About 31,000 people in the U.S. are projected to be diagnosed with the condition this year.

Approval for Polivy’s first-line treatment of DLBCL is based on data from POLARIX, a Phase 3, randomized, double-blind, placebo-controlled study that demonstrated a statistically significant and clinically meaningful improvement in progression-free survival compared to standard-of-care, according to the company. The most common adverse events reported were peripheral neuropathy, nausea, fatigue, diarrhea, constipation, alopecia, and mucositis. The most common Grade 3-4 adverse events were lymphopenia and neutropenia, it 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

Read more

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