Drugs

Favorable Pirtobrutinib Data in Leukemia/Lymphoma: Lilly

Eli Lilly says data from its confirmatory Phase 3 BRUIN CLL-321 trial evaluating Jaypirca (pirtobrutinib), a non-covalent (reversible) Bruton's tyrosine kinase (BTK) inhibitor, in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma met its primary endpoint of progression-free survival (PFS). The trial, which enrolled 238 patients who had already received one prior covalent BTK inhibitor, reportedly demonstrated that pirtobrutinib was superior to investigator's choice of idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR). FDA granted accelerated approval 12/2023 for Jaypirca in this patient population, and its continued marketing is contingent upon a successful confirmatory trial confirming its clinical benefit.

“Today’s updated results corresponding to the final prespecified analysis, demonstrate consistent improvement in PFS for patients treated with pirtobrutinib, with a reduction in risk of relapse, disease or death by 46% compared to IdelaR or BR,” Lilly says. The drug also demonstrated clinically meaningful improvements in secondary endpoints such as investigator-assessed PFS, event-free survival, and time to next treatment or death.

Regarding safety, Lilly says pirtobrutinib was associated with fewer Grade 3 or higher treatment-emergent adverse events and fewer treatment discontinuations due to adverse events compared to IdelaR or BR.

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