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What’s in Today’s Brief? (May 25th Preview)
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Regulatory approval: targeted protein degradation enters first FDA-backed oncology use
Vepdegestrant (Veppanu) — an oral CRBN-recruiting PROTAC from Array/ARV-471 — became the first FDA-approved PROTAC therapy in May 2026, marking a regulatory milestone for targeted protein degradation in oncology. The approval package is tied to efficacy against estrogen receptor–positive disease driven by both wild-type and ESR1-mutant ERα.
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FDA approval: sonrotoclax expands BCL2 inhibitor therapy in mantle cell lymphoma
FDA granted accelerated approval to Beqalzi (sonrotoclax), the first BCL2 inhibitor approved specifically for relapsed or refractory mantle cell lymphoma in adults after at least two prior lines including a BTK inhibitor. The decision was supported by phase 1/2 BGB-11417-201 data, including an overall response rate of 52% and a complete response rate of 16%.
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Gene editing: Lilly reports cholesterol reduction in early VERV-102 study
Eli Lilly said a high dose of its gene-editing therapy VERV-102 cut cholesterol by 62% in participants in a phase 1 trial, an early readout aimed at LDL lowering with a potential one-time approach. Lilly acquired the program from Verve Therapeutics as part of its $1 billion buyout.
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Oncology trials: DURABLE maintenance combination outperforms durvalumab alone in ES-SCLC
A multicenter randomized phase 2 trial dubbed DURABLE found that maintenance durvalumab plus anlotinib performed better than durvalumab monotherapy in extensive-stage small-cell lung cancer. The study evaluated efficacy and biomarker signals as part of an approach to intensify maintenance therapy in a setting with limited long-term options.
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Immuno-oncology pipeline readouts: ASCO cover key pre-meeting cost-utility and perioperative studies
Ahead of the 2026 ASCO Annual Meeting, several trial updates released with pre-meeting abstracts spotlight both clinical and health-economic endpoints across gastrointestinal and genitourinary oncology. Coverage includes cost-utility results from CHALLENGE in resected colon cancer and perioperative data in urothelial carcinoma from KEYNOTE-B15/EV-304, alongside CHRYSALIS-2 for atypical EGFR-mutant NSCLC.
...and 5 more selected Biotech stories in today’s full edition — or archive.
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