Drugs

FDA Grants Full Approval to Lilly’s Jaypirca

FDA has granted Eli Lilly traditional approval for Jaypirca (pirtobrutinib) and its use in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who were previously treated with a covalent BTK inhibitor. The action is based on confirmatory trial data and converts a 2023 accelerated approval, which covered patients who had received at least two prior lines of therapy including both a BTK inhibitor and a BCL-2 inhibitor.

Full approval was based on the randomized, open-label BRUIN-CLL-321 trial, which enrolled 238 previously treated CLL/SLL patients, according to an FDA release. Patients were randomized 1:1 to receive either pirtobrutinib, or investigator’s choice of idelalisib + rituximab (IR) or bendamustine + rituximab (BR).

The primary efficacy outcome measure was progression-free survival (PFS), as assessed by an independent review committee, FDA says. Median PFS was 11.2 months in the pirtobrutinib arm and 8.7 months in the investigator’s choice of IR/BR arm.

Jaypirca’s prescribing information carries Warnings for:

Serious infections
Hemorrhage
Cytopenias
Cardiac arrhythmias
Secondary malignancies
Hepatotoxicity
Embryo-fetal toxicity

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