Onco-Summaries: Daily Oncology Updates at a Glance

08/01/2026

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• Revolution Medicines' zoldonrasib received the FDA breakthrough therapy designation for KRAS G12D-mutated NSCLC

• 858 Therapeutics' ETX-19477 received the FDA fast track designation for BRCA-mutated HGSOC

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Revolution Medicines' zoldonrasib received the FDA breakthrough therapy designation for KRAS G12D-mutated NSCLC (Ref)

The US FDA granted the breakthrough therapy designation to Revolution Medicines' zoldonrasib (RAS(ON) G12D-selective inhibitor) for the treatment of adult patients with KRAS G12D-mutated locally advanced or metastatic NSCLC who have been previously treated with anti-PD-1/PD-L1 therapy and platinum-based chemotherapy.

• The designation is based on results from the Phase 1 RMC-9805-001 trial of zoldonrasib in patients with advanced KRAS G12D solid tumors

• Mark A. Goldsmith, M.D., Ph.D., CEO and Chairman, Revolution Medicines: “The Breakthrough Therapy Designation for zoldonrasib, our RAS(ON) G12D-selective covalent inhibitor – the first ever granted for an investigational drug specifically targeting the RAS G12D mutation – underscores the significant unmet need for patients with KRAS G12D cancers, which currently lack any approved targeted therapies.

  • This recognition expands upon prior designations for the RAS(ON) multi-selective inhibitor daraxonrasib and G12C-selective inhibitor elironrasib, further recognizing the promise of our first three clinical-stage RAS(ON) inhibitors as potentially transformative therapies for people living with RAS-addicted cancers.”

858 Therapeutics' ETX-19477 received the FDA fast track designation for BRCA-mutated HGSOC (Ref)

The US FDA granted the fast track designation to 858 Therapeutics' ETX-19477 (PARG inhibitor) for the treatment of adult patients with BRCA-mutated, platinum-resistant, high-grade serous ovarian cancer (HGSOC).

• Jeffrey Stafford, Ph.D., CEO, 858 Therapeutics: “Patients with platinum-resistant ovarian cancer have a poor prognosis, and treatment options remain extremely limited, highlighting a substantial unmet need for new therapies. We are pleased that the FDA has granted Fast Track designation to ETX-19477 and we are committed to working closely with the FDA to accelerate its development. This designation was based on preclinical data and emerging clinical data from our ongoing Phase 1/2 trial of ETX-19477, including anti-tumor activity at tolerable doses.”

• ETX-19477 is being evaluated in an ongoing Phase 1/2 study in patients with advanced solid tumors including Phase 1 backfill cohorts at multiple dose levels and enriching for select solid tumors harboring BRCA mutations, including HGSOC.