Regulatory Daily Summary
Regulatory Daily Summary: What Happened on October 5, 2026
FDA moves Jaypirca into first-line CLL and SLL treatment
Patented-drug tariffs are complicating company operations, while Surrozen won clearance to test an eye drug in people.
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Today in brief
The FDA approved Lilly’s Jaypirca as an initial treatment for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma who lack a 17p deletion.1 Tariffs of up to 100% on patented medicines and their ingredients took effect on September 29, as companies reported uncertainty over compliance and exemptions.2 The FDA also approved a gene therapy for a rare lysosomal storage disorder.3
Jaypirca gains a first-line role in CLL and SLL
Lilly’s oral drug Jaypirca, also called pirtobrutinib, can now treat adults with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who lack a 17p deletion.1 The FDA based its decision on a Phase 3 study of 282 patients comparing Jaypirca alone with bendamustine plus rituximab.1 After a median 28 months, independent reviewers found that Jaypirca reduced the risk of disease progression or death, with a hazard ratio of 0.20.1
Median progression-free survival had not been reached with Jaypirca, compared with 33.5 months with the comparator regimen.1 Overall response rates were 94% with Jaypirca and 81% with the comparator.1 Serious adverse reactions affected 28% of patients receiving Jaypirca, including pneumonia in 5%.1 Adverse events led to dose reductions in 3.6% of patients and treatment discontinuation in 4.3%.1
Drug tariffs are in force, but exemption rules remain a compliance concern
Tariffs of up to 100% on patented medicines and their ingredients took effect on September 29.2 Biotechnology companies say uncertainty about patent eligibility, reporting requirements, and exemptions is disrupting routine operations.2 The Department of Commerce says exemption reviews may consider the disease being treated, alternative therapies, US patient numbers, and availability abroad, with decisions made case by case.2
The guidance sets no deadline for decisions, and companies are unsure whether they must pay tariffs before seeking refunds for approved exemptions.2 Experts warn that tariff and compliance costs could divert money from research and affect medicine access and US competitiveness.2 BIO research found that small and midsize biotechnology companies account for 71% of industry output and 54% of new drug applications.2 Experts say smaller firms have less capital to absorb the costs.2
Also worth knowing
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The FDA cleared Surrozen’s SZN-8141 for clinical testing in diabetic macular edema. The company intends to dose the first participant in the DUET trial in the fourth quarter of 2026.4
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The FDA approved a gene therapy for a rare lysosomal storage disorder.3
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Novo is facing a delay in the US review of a hemophilia drug.5