Tecentriq (atezolizumab) was approved by the FDA on October 8, 2026 for adjuvant treatment of Stage III mismatch repair deficient (dMMR) colon cancer, with chemotherapy.
The FDA also approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), given under the skin, for the same use in patients 12 and older who weigh at least 40 kg. Recommended adult intravenous dose: 840 mg every two weeks, 1200 mg every three weeks or 1680 mg every four weeks with chemotherapy for six months, then atezolizumab alone for six months or until recurrence or unacceptable toxicity (FDA).
The FDA's approval notification is dated October 8, 2026 and states the approval was made that day. The goal date was October 9, 2026: Genentech said on June 10, 2026 that the FDA "is expected to make a decision on the approval by October 9, 2026" (Genentech, June 10, 2026). Both dates come from documents that state them, so the action came one day before the goal date. The approval is based on ATOMIC/ML39057 (NCT02912559), a multicenter, randomized, open-label, active-controlled trial in 711 adults and one pediatric patient with Stage III dMMR colon cancer after complete resection, comparing atezolizumab plus mFOLFOX6 (oxaliplatin, leucovorin and fluorouracil) for 12 cycles followed by atezolizumab for six months with mFOLFOX6 alone for 12 cycles. Per the FDA, the hazard ratio for investigator-assessed disease-free survival was 0.50 (95% CI 0.35 to 0.73; p 0.0001); median disease-free survival was not reached in either arm. The applications had priority review and were reviewed under Project Orbis with Australia's TGA, Health Canada, Israel's Ministry of Health and Swissmedic, whose reviews are ongoing. The FDA says full prescribing information will be posted on Drugs@FDA; the approval letter had not been posted there when this page was published.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
Primary source: FDA approval notification, atezolizumab with chemotherapy for Stage III dMMR colon cancer, October 8, 2026
FDA record of the action: the FDA approved on October 8, 2026, per FDA approval notification (sBLA; letter not yet on Drugs@FDA) (FDA notice). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.
Yes. The FDA approved the application for Tecentriq (atezolizumab) on October 8, 2026, per the FDA's own record. The primary source is linked on this page.
Tecentriq (atezolizumab) is a Genentech, a Roche company (RHHBY) program. The FDA decision came on October 8, 2026; the FDA's own record of the decision is linked on this page.
Measured over the 120 trading days before the decision (T-120 to T-1), RHHBY moved +3.0%. That is the recorded price path into this specific event. Historical measurement, not a prediction, and not investment advice.
The FDA approved atezolizumab (Tecentriq, Genentech) on October 8, 2026, in combination with a fluoropyrimidine and oxaliplatin, for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer, per the FDA's approval notification of that date. Genentech had given October 9, 2026 as the goal date, so the action came one day early.
ATOMIC/ML39057 (NCT02912559), a randomized, open-label, active-controlled trial in 711 adults and one pediatric patient with resected Stage III dMMR colon cancer, comparing atezolizumab plus mFOLFOX6 then atezolizumab alone with mFOLFOX6 alone. The disease-free survival hazard ratio was 0.50 (95% CI 0.35 to 0.73; p 0.0001), per the FDA.
Yes. The same FDA notification approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of patients 12 years and older who weigh 40 kg or more with Stage III dMMR colon cancer.
For adults the FDA gives 840 mg every two weeks, 1200 mg every three weeks or 1680 mg every four weeks intravenously with chemotherapy for six months, then atezolizumab alone for six months or until disease recurrence or unacceptable toxicity. The FDA says full prescribing information will be posted on Drugs@FDA.