Onco-Summaries: Daily Oncology Updates at a Glance

12/05/2026

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• FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid cystic carcinoma

  
  

• Rigel secures global rights to VEPPANU, the first FDA‑approved oral PROTAC, with strong Phase 3 data in ER+/HER2‑, ESR1‑mutated breast cancer

  
  

• ZUSDURI delivers 64.5% 3‑year event‑free durability in recurrent LG‑IR‑NMIBC

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FDA grants Breakthrough Therapy Designation to Servier’s B7‑H4 ADC Emiltatug Ledadotin (Emi‑Le) for advanced adenoid cystic carcinoma (Ref)

FDA Breakthrough Therapy Designation: Emiltatug Ledadotin (Emi‑Le), an investigational antibody‑drug conjugate (ADC) targeting B7‑H4, has been granted breakthrough therapy designation by the U.S. FDA for locally advanced, recurrent, or metastatic adenoid cystic carcinoma (ACC) with solid histology or high‑grade transformation

Emi‑Le is in a multicenter Phase 1 trial evaluating safety, tolerability, and anti‑tumor activity in solid tumors including ACC, breast, endometrial, and ovarian cancers. Early data showed manageable side effects and confirmed objective responses across multiple tumor types

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Rigel secures global rights to VEPPANU, the first FDA‑approved oral PROTAC, with strong Phase 3 data in ER+/HER2‑, ESR1‑mutated breast cancer (Ref)

Rigel Pharmaceuticals entered an exclusive global licensing deal with Arvinas and Pfizer to develop, manufacture, and commercialize VEPPANU™ (vepdegestrant), the first FDA-approved oral PROTAC for ER+/HER2-, ESR1-mutated advanced or metastatic breast cancer

FDA approved VEPPANU on May 1, 2026 for adults with ER+/HER2-, ESR1-mutated

advanced/metastatic breast cancer after at least one endocrine therapy

Added to NCCN Guidelines (Category 2A) for HR+/HER2-, ESR1-mutated disease after endocrine therapy + CDK4/6 inhibitor

Arvinas and Pfizer receive $70M upfront, $15M upon transition, plus up to $320M in milestones and tiered royalties (mid-teens to mid-twenties)

Rigel gains global commercialization rights and will lead the U.S. launch

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ZUSDURI delivers 64.5% 3‑year event‑free durability in recurrent LG‑IR‑NMIBC (Ref)

In Ph3 ENVISION  trial, ZUSDURI delivers durable 3-year disease-free outcomes in recurrent LG-IR-NMIBC without maintenance therapy, positioning it as a non-surgical paradigm-shifting alternative to TURBT

• 36-month duration of response (DOR): 64.5% probability of remaining event-free after achieving complete response (CR) at 3 months (79.6% CR rate)

• Median DOR not yet reached at 35.5 months follow-up

• Durable outcomes achieved without maintenance therapy, with stable event rates over time

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