Divarasib History and Updates

39 events · 2017 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
39
Trial Milestones
0
Pivotal Publications
Divarasib — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20172018201920202021202220232024202520262027202820292030203120322033Trial: NCT07541170 2026-09-01 → 2032-01-31 (primary completion)Trial: NCT06793215 2025-10-24 → 2028-11-30 (primary completion)Trial: NCT06835465 2025-02-21 → 2025-05-06 (primary completion)Trial: NCT06734208 2025-01-31 → 2025-11-27 (primary completion)Trial: NCT06690138 2024-11-15 → 2025-02-11 (primary completion)Trial: NCT06677957 2024-11-06 → 2024-12-30 (primary completion)Trial: NCT06497556 2024-09-23 → 2027-09-30 (primary completion)Trial: NCT05789082 2023-06-20 → 2032-01-29 (primary completion)Trial: NCT05862285 2023-06-01 → 2033-03-01 (primary completion)Trial: NCT04929223 2021-10-22 → 2030-08-31 (primary completion)Trial: NCT04589845 2021-01-18 → 2032-09-25 (primary completion)Trial: NCT04302025 2020-11-06 → 2026-11-30 (primary completion)Trial: NCT03178552 2017-09-22 → 2026-10-31 (primary completion)today (2026-06-10)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-10Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Divarasib since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07541170
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants
Primary completion· ClinicalTrials.gov
Phase 2/Phase 3 primary completion: NCT03178552
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (N
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04302025
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06497556
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-posi
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06793215
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin i
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04929223
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT05789082
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therap
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07541170
A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04589845
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT05862285
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study

Past events

2026
2025
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06734208
A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06793215
A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin i
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06835465
A Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Divarasib in Healthy Participants
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06690138
A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06734208
A Study to Evaluate the Pharmacokinetics of Divarasib in Healthy Participants and Participants With Impaired Hepatic Function
2024
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06677957
A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Re
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06690138
A Study to Determine the Effect of Itraconazole on the Pharmacokinetics of Divarasib in Healthy Participants
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06677957
A Clinical Trial to Investigate the Clinical Drug-Drug Interaction of Divarasib With Probe Substrates of P-Glycoprotein and Breast Cancer Re
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06497556
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-posi
2023
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT05789082
A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therap
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT05862285
A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
2021
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04929223
A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04589845
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
2020
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04302025
A Study of Multiple Therapies in Biomarker-selected Participants With Resectable Stages IB-III Non-small Cell Lung Cancer (NSCLC)
2017
Trial started· ClinicalTrials.gov
Phase 2/Phase 3 trial started: NCT03178552
A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (N

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.