Divarasib approval has no confirmed date, but Roche’s own guidance points to 2027. Roche’s Pharma Day slides of 28 September 2026 list US and EU approval as a 2027 milestone. No regulatory filing for the KRAS G12C inhibitor had been announced in the sources reviewed on 27 October 2026. Roche said on 2 July 2026 that it would submit the Krascendo 1 data to health authorities. Full results followed on 25 October 2026 at the ESMO Congress in Madrid.
A Roche deputy chief medical officer declined to give a filing timeline, according to Fierce Biotech. This article sets out what the trial showed, what remains unknown, and what would settle the question. For background on how KRAS G12C became druggable, see the feature on undruggable proteins.
What did Krascendo 1 show on 25 October 2026?
Krascendo 1 (NCT06497556) is a randomised, open-label phase 3 trial in previously treated, KRAS G12C-mutated non-small cell lung cancer. It randomised 338 adults, according to Genentech’s release. Of these, 167 received divarasib once daily. The other 171 received investigator’s choice of sotorasib or adagrasib.
OncLive reported that 156 control patients received sotorasib and 15 received adagrasib. Crossover was not permitted. The primary endpoint was progression-free survival (PFS), assessed by blinded independent central review. The results were published the same day in the New England Journal of Medicine. Ferdinandos Skoulidis of MD Anderson Cancer Center is first author.
Efficacy results
Median PFS was 9.8 months with divarasib and 5.7 months with the control drugs. The hazard ratio was 0.58 (95 per cent confidence interval 0.44 to 0.76). Median overall survival, a key secondary endpoint, was 17.7 months against 12.0 months. That hazard ratio was 0.56 (0.41 to 0.78), from a first interim analysis. Genentech’s release said the survival and PFS benefit was consistent across clinically relevant subgroups. That included PD-L1 expression and KEAP1 mutation status.
Confirmed objective response was 58 per cent against 32 per cent in the response-evaluable population. Median duration of response was 11.9 months against 6.9 months.
Safety results
Safety deserves equal weight. Treatment-related discontinuation was 4.8 per cent with divarasib and 11.7 per cent with control. Serious treatment-related events were 7.8 per cent against 15.2 per cent. Grade 3 or 4 treatment-related events were 24.6 per cent against 34.5 per cent, OncLive reported.
Some findings favoured the control arm. OncLive reported any-grade treatment-related events in 92.8 per cent with divarasib against 80.1 per cent. Diarrhoea occurred in 66 per cent against 38 per cent. Nausea occurred in 53 per cent against 20 per cent. Vomiting occurred in 39 per cent against 8 per cent. OncLive reported grade 1 rates with divarasib of 35, 32 and 8 per cent respectively.
Liver enzyme rises were less frequent with divarasib. ALT increases occurred in 15 per cent against 23 per cent. Median time on treatment was 11.3 months against 5.0 months, so drug exposure differed between arms. OncLive reported no grade 5 treatment-related events in either arm.
What is the divarasib approval timeline?
Roche has not announced a filing date. Stefan Frings, deputy chief medical officer at Roche Pharma, told Fierce Biotech the data should convince health authorities. He declined to give a filing timeline. Fierce Biotech also reported that Roche is aiming for peak sales of CHF 1 billion to 2 billion.
Roche’s Pharma Day presentation on 28 September 2026 goes further. It lists divarasib in second-line lung cancer among potential launches by the end of 2027. It also lists US and EU approval as a 2027 regulatory milestone. That is company guidance, not a regulatory commitment.
Roche’s 2 July release lists two FDA designations. Breakthrough Therapy Designation was granted in 2022. Orphan Drug Designation for KRAS G12C-mutated lung cancer was granted in 2026. The release does not link either designation to a review timetable. The FDA drug approval decisions tracker lists dated decisions. A check on 27 October 2026 found no divarasib entry.
The practical question for clinicians is when divarasib approval could change prescribing. That depends on the first filing. Roche’s July release said only that it would submit the data. It gave no date, no region and no regulatory route. Those details would define any divarasib approval timeline.
A US decision date normally follows acceptance of an application. No acceptance had been announced in the sources reviewed on 27 October 2026. No UK or European submission had been announced either.
What the UK label for sotorasib shows
The Great Britain label for the comparator sotorasib sets the benchmark. The emc summary of product characteristics for Lumykras was revised on 8 July 2026. It carries a conditional marketing authorisation and additional monitoring status. Its indication covers adults with KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer. They must have progressed on, or be intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy.
An emc search for Krazati on 27 October 2026 returned no results. That finding does not show the product is unauthorised in Great Britain.
Where the comparators stand in the US
Both comparators were first approved in the US on an accelerated basis. The FDA’s approval letter for adagrasib is dated 12 December 2022. Amgen said on 26 December 2023 that sotorasib’s US indication rests on accelerated approval. It also said the FDA had issued a complete response letter on full approval.
Amgen added that the FDA required another confirmatory study, due for completion by February 2028. A search on 27 October 2026 found no announcement converting either accelerated approval. Current US labels were not read for this article.
What are the limits of the divarasib data?
Several caveats apply. The trial was open-label, and crossover was not permitted. The control arm pooled two drugs. OncLive’s figures put about 91 per cent of control patients on sotorasib. That limits what the result says about adagrasib alone. Control dosing also differed. Sotorasib was given once daily and adagrasib twice daily.
The overall survival analysis was interim. Subgroup results varied. In KEAP1-mutated disease, OncLive reported PFS of 4.6 against 2.8 months (hazard ratio 0.56; 0.33 to 0.92). With prior CNS metastases, PFS was 6.8 against 5.7 months. That hazard ratio was 0.74, and its interval of 0.47 to 1.17 includes 1.
Sponsor and investigator views are favourable. Levi Garraway, Roche’s chief medical officer, is quoted in the Genentech release. He said the results show “the potential for divarasib to become a new standard of care”. That is a company statement. Prof Benjamin Besse of Gustave Roussy spoke to Clinical Trials Arena. He said divarasib’s higher potency “could translate into a new standard of care”.
These data do not allow comparison with other KRAS G12C agents. Such comparisons would be cross-trial.
What would settle the divarasib approval question?
Regulators would weigh the survival benefit against the tolerability findings. The open-label design and the pooled control arm are relevant to that judgement. So is the gastrointestinal toxicity. Those judgements belong to the FDA, the MHRA and the EMA. They are not yet known. A divarasib approval in second-line disease would also depend on the maturing survival data.
Three developments would answer it. The first is an announcement of a filing with the FDA, the MHRA or the EMA. The second is regulator acceptance of that filing, which would bring a review timetable. The third is mature overall survival data from Krascendo 1.
Roche’s wider programme adds context. Krascendo 2 (NCT06793215) combines divarasib with pembrolizumab in first-line disease, and Fierce Biotech described it as recruiting. Krascendo 3 (NCT07541170) tests adjuvant use, and Roche’s 19 October release described it as in progress. Readers tracking divarasib approval should watch for the filing announcement first. Until a filing is accepted, Roche’s 2027 target for divarasib approval remains company guidance.
