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Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jun 12
- 1 min read
11/06/2026
FDA grants Priority Review for atezolizumab + chemo in stage III dMMR/MSI-H colon cancer (Ref)
The FDA has accepted Roche’s supplemental Biologics License Application (sBLA) and granted priority review for Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy for stage III Colon cancer characterized by deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H).
A decision is expected by October 9, 2026
The application is based on the Ph3 ATOMIC study
Results showed that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of recurrence or death by 50% compared to chemotherapy alone. 36-month disease-free survival was 86% with Tecentriq + FOLFOX6 vs 76% with FOLFOX6 alone
Roche is pursuing additional regulatory filings, including with the European Medicines Agency, to make Tecentriq the first immunotherapy-based adjuvant option for dMMR/MSI-H colon cancer worldwide
Alembic wins tentative USFDA approval for Larotrectinib capsules (Ref)
Alembic Pharmaceuticals received tentative approval for its Abbreviated New Drug Application (ANDA) for Larotrectinib Capsules (25 mg and 100 mg)
The capsules are therapeutically equivalent to Vitrakvi (Bayer Healthcare)
Larotrectinib is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that:
Have an NTRK gene fusion without known resistance mutations
Are metastatic or where surgery would cause severe morbidity
Lack satisfactory alternative treatments or have progressed after prior therapy
Alembic is the sole first applicant with a Paragraph IV filing, making it eligible for 180 days of generic marketing exclusivity in the U.S. upon final approval
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