Drugs

Lilly Gets Accelerated Approval for Lymophoma Drug

FDA has granted Eli Lilly accelerated approval for Jaypirca (pirtobrutinib) for treating relapsed or refractory mantle cell lymphoma (MCL) patients who have had at least two lines of systemic therapy, including a BTK inhibitor. Approval was based on data from the BRUIN (NCT03740529) single-arm trial of pirtobrutinib monotherapy in 120 patients with MCL previously treated with a BTK inhibitor, according to an agency release. The overall response rate was 50%, with a complete response rate of 13%, it says, adding that the estimated median duration of response (DoR) was 8.3 months, and the estimated DoR rate at six months was 65.3%.

On the safety side, the most common adverse reactions in patients with MCL were fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, and bruising,” FDA says. “Grade 3 or 4 laboratory abnormalities in greater than or equal to 10% of patients were decreased neutrophil counts, lymphocyte counts, and platelet counts,” it adds. Additionally, the prescribing information includes warnings and precautions for infections, hemorrhage, cytopenias, atrial fibrillation and flutter, and second primary malignancies.

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