Tecentriq (atezolizumab) is a Roche Holding AG program in in combination with a fluoropyrimidine and oxaliplatin, adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The FDA approved it on Oct 8, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: in combination with a fluoropyrimidine and oxaliplatin, adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer (approved Oct 8, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Roche Holding AG (RHHBY). Approval record: Supplemental BLA, Priority Review, reviewed under Project Orbis. ATOMIC/ML39057 (NCT02912559): 711 adults and one pediatric patient with resected Stage III dMMR colon cancer, randomized 1:1 to atezolizumab plus mFOLFOX6 for 12 cycles then atezolizumab for 6 months, or mFOLFOX6 alone; investigator-assessed DFS hazard ratio 0.50 (95% CI 0.35 to 0.73; p 0.0001), median DFS not reached in either arm. Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) approved for the same use in patients 12 and older weighing at least 40 kg (FDA notification). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for Tecentriq (atezolizumab); 1 FDA decision is on record below.
On Oct 8, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Tecentriq (atezolizumab) is FDA-approved for in combination with a fluoropyrimidine and oxaliplatin, adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer (approved Oct 8, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Roche Holding AG (RHHBY).
Yes. The FDA approved an application for Tecentriq (atezolizumab) on Oct 8, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.