Divarasib Market Summary

Key Factors Driving Divarasib Growth

1. High response rates and durable disease control in earlier clinical studies support its best-in-class positioning: In the Phase I study, divarasib produced a confirmed ORR of 53.4% and median PFS of 13.1 months in KRAS G12C-positive NSCLC. Longer follow-up subsequently showed an ORR of 55.6%, median duration of response of 18.0 months, and median PFS of 13.8 months; at the recommended 400-mg dose, median PFS reached 15.3 months. These results are substantially encouraging for a heavily pretreated population and helped establish the biological rationale for the Phase III program.

2. Large and clinically important KRAS G12C-positive NSCLC population: KRAS G12C is found in approximately 14% of NSCLC cases, according to Roche. This makes it one of the most common actionable oncogenic alterations in NSCLC. A successful divarasib launch could therefore address a considerably larger population than drugs targeting rare molecular subsets. Roche is also testing divarasib in different lines of therapy, potentially increasing the treated population over time.

3. Strong potential in colorectal cancer through combination with cetuximab: Divarasib has shown particularly promising activity when combined with EGFR inhibition. In a Phase Ib study of KRAS G12C-positive CRC, divarasib + cetuximab produced a 62.5% ORR in KRAS G12C-inhibitor-naïve patients, with median PFS of 8.1 months and median duration of response of 6.9 months. The rationale is important because EGFR signaling can reactivate the MAPK pathway and contribute to resistance to KRAS G12C inhibition in CRC. This combination strategy could therefore create a second major commercial indication if later-stage trials are successful.

4. Expansion into first-line NSCLC could substantially enlarge the addressable market: Roche is conducting the Phase III KRAScendo 2 trial evaluating divarasib + pembrolizumab as a chemotherapy-free first-line regimen against chemotherapy + pembrolizumab in previously untreated KRAS G12C-positive advanced NSCLC. Earlier Phase Ib/II data presented by Roche showed encouraging activity with the combination. Moving from a post-treatment population into first-line NSCLC would allow divarasib to compete for patients earlier in the disease course and potentially increase treatment duration and patient exposure.

5. Multiple additional indications create significant lifecycle-expansion potential: Roche is also evaluating divarasib in resected stage II–IIIB KRAS G12C-positive NSCLC in the Phase III KRAScendo 3 trial, comparing it with investigator's choice of immunotherapy or observation after neoadjuvant chemoimmunotherapy. Roche is additionally investigating the molecule in pancreatic adenocarcinoma, cholangiocarcinoma and other solid tumors. Successful expansion into earlier-stage disease would materially increase the potential treatment pool beyond metastatic NSCLC/CRC.

Divarasib Recent Developments

In July 2026, Roche announced that the Phase III KRAScendo 1 trial met both its primary PFS and key OS endpoints, showing statistically significant and clinically meaningful improvements versus the approved KRAS G12C inhibitors sotorasib and adagrasib. The trial enrolled 338 patients with previously treated advanced/metastatic KRAS G12C-positive NSCLC. Roche reported no new safety signals.

“Divarasib Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of Divarasib for potential indication like Non-small cell lung cancer, Breast cancer, and Solid tumours in the 7MM. A detailed picture of Divarasib’s existing usage in anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the Divarasib for potential indications. The Divarasib market report provides insights about Divarasib’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Divarasib performance, future market assessments inclusive of the Divarasib market forecast analysis for potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Divarasib sales forecasts, along with factors driving its market.

Divarasib Drug Summary

Divarasib (GDC-6036/RG6330) is an investigational, orally administered, highly potent and selective covalent inhibitor of the KRAS G12C mutation, developed by Genentech/Roche for the treatment of KRAS G12C-mutated solid tumors, particularly non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). It selectively binds to the mutant cysteine residue at position 12 of KRAS and irreversibly locks KRAS G12C in its inactive GDP-bound state, thereby suppressing oncogenic signaling pathways involved in tumor-cell proliferation and survival. In a Phase I study, divarasib was administered orally once daily at doses of 50–400 mg; among patients with KRAS G12C-mutated NSCLC, the confirmed objective response rate was 53.4%, while the confirmed response rate in colorectal cancer was 29.1%. Divarasib remains investigational and has not received FDA approval; however, the FDA granted it Orphan Drug Designation in April 2026 for the treatment of KRAS G12C-positive NSCLC. Common treatment-related adverse events observed in clinical development have included gastrointestinal toxicities and other generally manageable adverse events, with most reported events being low grade. The report provides Divarasib’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Divarasib Market Report

The report provides insights into:

• A comprehensive product overview including the Divarasib MoA, description, dosage and administration, research and development activities in potential indication like Non-small cell lung cancer, Breast cancer, and Solid tumours.
• Elaborated details on Divarasib regulatory milestones and other development activities have been provided in Divarasib market report.
• The report also highlights Divarasib‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in potential indications across the United States, Europe, and Japan.
• The Divarasib market report also covers the patents information, generic entry and impact on cost cut.
• The Divarasib market report contains current and forecasted Divarasib sales for potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Divarasib market report also features the SWOT analysis with analyst views for Divarasib in potential indications.

Methodology

The Divarasib market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Divarasib Analytical Perspective by DelveInsight

• In-depth Divarasib Market Assessment

This Divarasib sales market forecast report provides a detailed market assessment of Divarasib for potential indication like Non-small cell lung cancer, Breast cancer, and Solid tumours in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Divarasib sales data uptil 2034.

• Divarasib Clinical Assessment

The Divarasib market report provides the clinical trials information of Divarasib for potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

Divarasib Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

Divarasib Market Potential & Revenue Forecast

• Projected market size for the Divarasib and its key indications
• Estimated Divarasib sales potential (Divarasib peak sales forecasts)
• Divarasib Pricing strategies and reimbursement landscape

Divarasib Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• Divarasib Market positioning compared to existing treatments
• Divarasib Strengths & weaknesses relative to competitors

Divarasib Regulatory & Commercial Milestones

• Divarasib Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

Divarasib Clinical Differentiation

• Divarasib Efficacy & safety advantages over existing drugs
• Divarasib Unique selling points

Divarasib Market Report Highlights

• In the coming years, the Divarasib market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The Divarasib companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Divarasib’s dominance.
• Other emerging products for Non-small cell lung cancer, Breast cancer, and Solid tumours are expected to give tough market competition to Divarasib and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Divarasib in potential indications.
• Analyse Divarasib cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Divarasib sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Divarasib in potential indications.

Key Questions

• What is the class of therapy, route of administration and mechanism of action of Divarasib? How strong is Divarasib’s clinical and commercial performance?
• What is Divarasib’s clinical trial status in each individual indications such as Non-small cell lung cancer, Breast cancer, and Solid tumours and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Divarasib Manufacturers?
• What are the key designations that have been granted to Divarasib for potential indications? How are they going to impact Divarasib’s penetration in various geographies?
• What is the current and forecasted Divarasib market scenario for potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Divarasib in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
• What are the other emerging products available and how are these giving competition to Divarasib for potential indications?
• Which are the late-stage emerging therapies under development for the treatment of potential indications?
• How cost-effective is Divarasib? What is the duration of therapy and what are the geographical variations in cost per patient?