Drugs

Oncologic Panel to Review 4 Cancer Submissions

FDA is announcing a two-day (5/20-21) Oncologic Drugs Advisory Committee meeting to review and vote on four cancer drug submissions. During the morning session on 5/20, panel members will discuss a supplemental BLA for Genentech’s Columvi (glofitamab) injection and its use in combination with gemcitabine and oxaliplatin for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma who are not candidates for autologous stem cell transplant (ASCT). In the afternoon on 5/20, they will discuss a Janssen Biotech supplemental BLA for Darzalex Faspro (daratumumab and hyaluronidase) injection and its use as monotherapy for treating adult patients with high-risk smoldering multiple myeloma.

On 5/21, the morning session will discuss a UroGen Pharma NDA for mitomycin intravesical solution for treating adult patients with low-grade intermediate-risk non-muscle invasive bladder cancer. The afternoon session will discuss a Pfizer supplemental NDA for Talzenna (talazoparib) capsules and its use in combination with enzalutamide for treating adult patients with metastatic castration-resistant prostate cancer.

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