Oncology ·
FDA approves pirtobrutinib for untreated CLL; tiles cut brain metastasis recurrence; protons fail to extend liver cancer survival
THE SHORT READ
The Food and Drug Administration (FDA) on Oct. 2 approved Eli Lilly's pirtobrutinib for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion.
A phase 3 trial published Sept. 28 in the Journal of Clinical Oncology found radiation tiles placed during brain metastasis surgery cut surgical bed recurrence. At the American Society for Radiation Oncology meeting, protons did not improve survival over photons in liver cancer. Bayer said the FDA granted priority review to elinzanetant for hot flashes during breast cancer endocrine therapy.
THE DETAILS
- FDA Oct 2, 2026The Food and Drug Administration approved pirtobrutinib (Jaypirca, Eli Lilly) on Oct. 2 for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion. In the BRUIN CLL-313 trial, 282 patients were randomized 1:1 to pirtobrutinib or bendamustine plus a rituximab product; median progression-free survival was not estimable with pirtobrutinib and 33.5 months with bendamustine-rituximab (hazard ratio 0.20, 95% CI 0.11 to 0.37). The most common non-laboratory adverse reactions were upper respiratory tract infections (27%), rash (22%) and COVID-19 (21%). Lilly called Jaypirca the first and only approved non-covalent Bruton tyrosine kinase inhibitor.Sources: FDA, Eli Lilly and Company
- Research Sept 28, 2026The phase 3 ROADS trial, first presented at the 2026 American Society of Clinical Oncology meeting and published Sept. 28 in the Journal of Clinical Oncology, compared GammaTile cesium-131 tiles placed during resection with postoperative stereotactic radiation for newly diagnosed brain metastases. Among 204 of 230 randomized patients, median time to surgical bed recurrence was not reached with tiles versus 17.4 months (hazard ratio 0.06), Targeted Oncology reported. MD Anderson said one-year surgical site recurrence was 1.3% versus 15.4% and median overall survival, a secondary end point, 42.5 versus 17.6 months, with no differences in serious treatment-related side effects.Sources: MD Anderson Cancer Center, Targeted Oncology
- Research Sept 29, 2026Proton therapy did not improve overall survival compared with photon therapy in NRG-GI003, a phase 3 trial of 115 eligible patients with advanced hepatocellular carcinoma presented in the plenary session of the American Society for Radiation Oncology (ASTRO) annual meeting in Boston, NRG Oncology reported Sept. 29. Overall survival at 24 months was 56.2% with protons and 69.3% with photons (hazard ratio 1.30, 90% CI 0.83 to 2.04). Grade 3 or higher treatment-related adverse events occurred in 11% of proton patients versus 24% of photon patients, a difference that was not statistically significant.Sources: NRG Oncology (via ecancer), Targeted Oncology
- Research Oct 1, 2026The New England Journal of Medicine published the phase 3 evERA trial on Oct. 1, comparing giredestrant plus everolimus with standard endocrine therapy plus everolimus in ER-positive, HER2-negative locally advanced or metastatic breast cancer previously treated with a CDK4/6 inhibitor and endocrine therapy. In the ESR1-mutated population, median progression-free survival was 10.0 versus 5.5 months (hazard ratio 0.38, 95% CI 0.27 to 0.54), Targeted Oncology reported. In the intention-to-treat population, it was 8.8 versus 5.5 months (hazard ratio 0.56, 95% CI 0.44 to 0.71).
- FDA Sept 28, 2026Bayer said Sept. 28 that the Food and Drug Administration accepted its supplemental new drug application and granted priority review for elinzanetant (Lynkuet) to treat moderate to severe vasomotor symptoms in women receiving endocrine therapy for treatment or prevention of hormone receptor-positive breast cancer. In the phase 3 OASIS-4 trial of 474 patients, daily vasomotor symptom frequency fell by a mean of 6.5 episodes with elinzanetant versus 3.0 with placebo by week 4, and by 7.8 versus 4.2 by week 12, Targeted Oncology reported. Elinzanetant was first approved in the U.S. in October 2025 for vasomotor symptoms due to menopause.Sources: Bayer, Targeted Oncology
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