Provenance Record

News-category (well within range), Overview / Trial and Efficacy / Dosing and Mechanism / Confirmatory Trial / Reactions / What We Don't Know structure. Clinical, precise, neutral tone. Properly notes accelerated-approval requires confirmatory verification, names the trial, distinguishes the 103-patient efficacy population from the 115-patient safety population.

{"source-0":{"url":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sonrotoclax-relapsed-or-refractory-mantle-cell-lymphoma","snapshot":"source-0.html.gz","status":"Primary publication (Rule 9): FDA approval announcement. Confirms sonrotoclax + accelerated approval + mantle cell lymphoma framing."},"source-1":{"url":"https://www.ons.org/publications-research/voice/news-views/05-2026/fda-grants-accelerated-approval-sonrotoclax-relapsed","snapshot":"source-1.html.gz","status":"Oncology Nursing Society. Verifies May 13 dateline, BTK inhibitor + ≥2 lines indication, 320 mg once-daily dose, four-week ramp-up."},"source-2":{"url":"https://ascopost.com/news/may-2026/sonrotoclax-receives-accelerated-approval-in-relapsed-or-refractory-mcl/","snapshot":"source-2.html.gz","status":"ASCO Post. Verifies BGB-11417-201 / NCT05471843, 103 patients, 52% ORR, 1.9-month TTR, 15.8-month DoR, 11.9-month follow-up, 115 safety population, 37% serious AE, 10% pneumonia."},"source-3":{"url":"https://www.biospace.com/press-releases/beone-medicines-beqalzi-sonrotoclax-approved-by-u-s-fda-as-first-and-only-bcl2-inhibitor-for-r-r-mantle-cell-lymphoma","snapshot":"source-3.html.gz","status":"BioSpace republication of BeOne press release. Verifies 7% TLS, 14% serious infections / 17% Gr 3-4 / 2.6% fatal, 18% Gr 3-4 neutropenia / 6% Gr 4, fast track designation."},"source-4":{"url":"https://healthtree.org/mantle-cell-lymphoma/community/articles/26-fda-approves-sonrotoclax-beqalzi-mcl","snapshot":"source-4.html.gz","status":"HealthTree (patient advocacy / oncology community outlet). Verifies Michael Wang 'foundational therapy' quote verbatim."},"source-5":{"url":"https://medcitynews.com/2026/05/beone-medicines-fda-approval-mantle-cell-lymphoma-sonrotoclax-beqlazi-bcl2-onc/","snapshot":"null (HTTP 403)","status":"MedCity News: bot-blocked, snapshot failed. Verified directly via WebFetch — Leerink $100M 2030 forecast, 4-6h vs 26h half-life comparison, Basel HQ, off-label venetoclax framing all verbatim in the live page."},"source-6":{"url":"https://www.pharmaceutical-technology.com/news/regulatory-roundup-fda-cancer-approvals-may-2026/","snapshot":"source-6.html.gz (Archive.org fallback)","status":"Pharmaceutical Technology (via Archive.org). Verifies CELESTIAL-RRMCL NCT06742996 confirmatory trial, 149 locations across 17 countries, 16% CR rate, 'first BCL-2' framing."}}

Solid FDA-approval coverage. Every clinical specific verified verbatim across 6 reachable snapshots (MedCity validated separately via WebFetch). Verified: May 13, 2026 approval date, R/R MCL ≥2 prior lines including BTKi label, 320 mg once-daily dose, four-week ramp-up (ONS); BGB-11417-201 + NCT05471843 trial identifier, 103-patient single-arm Phase 1/2 design, 52% ORR with 95% CI 42-62, 1.9-month median time to response, 15.8-month median DoR with 95% CI 7.4-NE, 11.9-month median follow-up, 115-patient safety population, 37% serious adverse reactions, pneumonia 10% (ASCO Post); 7% TLS at recommended ramp-up, 14% serious infections with 17% Grade 3-4 + 2.6% fatal, 18% Grade 3-4 neutropenia with 6% Grade 4, fast track designation (BioSpace press release); Michael Wang 'foundational therapy' quote (HealthTree); $100M Leerink Beqalzi MCL 2030 sales estimate verbatim 'Leerink Partners models Beqalzi will reach about $100 million in sales in the MCL indication by 2030', 4-6h vs 26h half-life comparison verbatim 'It's also designed with a short half-life — four to six hours versus about 26 hours for Venclexta', Basel Switzerland HQ, off-label venetoclax in MCL framing (MedCity, verified via WebFetch since snapshot returned 403); CELESTIAL-RRMCL NCT06742996 confirmatory trial + 149 locations across 17 countries + 16% CR rate + 'first BCL-2 inhibitor' framing (Pharmaceutical Technology, Archive.org fallback). FDA primary press release cited as source-0 (Rule 9 compliance).