Drugs

Genmab BLA OK’d for Large B-cell Lymphoma

FDA has granted Genmab an accelerated approval for its BLA for Epkinly (epcoritamab-bysp) injection for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B‑cell lymphoma after two or more lines of systemic therapy. DLBCLs are the most common type of non-Hodgkin lymphoma cancer and are associated with rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other tissues and organs, the agency says. Epkinkly is intended to be administered subcutaneously in 28-day cycles until disease progression or unacceptable toxicity, it adds.

Approval was based on data from a study entitled EPCORE NHL-1 (NCT03625037) that involved 148 patients with relapsed or refractory DLBCL that measured overall response rate (ORR). FDA says the study showed that the ORR was 61% with 38% of patients achieving complete responses. “With a median follow-up of 9.8 months among responders, the estimated median duration of response was 15.6 months,” it says.

FDA notes that the prescribing information includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS) and life-threatening or fatal immune effector cell-associated neurotoxicity syndrome (ICANS). “Among the 157 patients with relapsed or refractory large B-cell lymphoma who received Epkinly at the recommended dose, CRS occurred in 51% of patients, ICANS in 6%, and serious infections in 15%,” the agemcy 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

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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