New Colon Cancer Approval + FDA Breakthrough Designations - Oncology Updates copertina

New Colon Cancer Approval + FDA Breakthrough Designations - Oncology Updates

New Colon Cancer Approval + FDA Breakthrough Designations - Oncology Updates

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New regulatory developments and practice-relevant data feature in this week’s Oncology Updates from ONCOassist.

Dr. Stephanie Haddad, Hematology/Oncology Fellow and Academic Chief Fellow at UT Health San Antonio/Mays Cancer Center, covers:

🔹 Multiple Myeloma: A transplant-ineligible subgroup analysis from the Phase III CEPHEUS trial showed that adding daratumumab to VRd reduced the hazard of progression or death by 49% compared with VRd alone (HR 0.51), while increasing MRD negativity to 60.4% versus 39.3%.

🔹 Colorectal Cancer & NSCLC: The c-Met-directed antibody-drug conjugate telisotuzumab adizutecan received two FDA Breakthrough Therapy Designations, one in combination with bevacizumab in refractory metastatic colorectal cancer and another as monotherapy in previously treated EGFR wild-type, c-Met-expressing non-squamous NSCLC. These are Breakthrough Therapy Designations, not FDA approvals.

🔹 Stage III dMMR Colon Cancer: The FDA approved atezolizumab plus chemotherapy for adjuvant treatment. In the Phase III ATOMIC trial, adding atezolizumab to modified FOLFOX6 reduced the hazard of recurrence or death by 50%, with 36-month disease-free survival of 86% versus 76%.

🔹 ER+/HER2− Breast Cancer: Guardant360 CDx received CE marking in Europe as a companion diagnostic for camizestrant in locally advanced or metastatic disease. The blood test can detect ESR1 mutations before disease progression, supporting ctDNA-guided treatment selection.

Reference Links:

https://ascopubs.org/doi/10.1200/JCO-26-00401

https://news.abbvie.com/2026-10-07-AbbVies-Telisotuzumab-Adizutecan-Temab-A-Receives-Two-Breakthrough-Therapy-Designations-From-the-U-S-FDA-for-CRC-and-NSCLC

https://www.globenewswire.com/news-release/2026/10/09/3377811/0/en/fda-approves-roche-s-tecentriq-in-combination-with-a-fluoropyrimidine-and-oxaliplatin-for-the-adjuvant-treatment-of-a-certain-type-of-stage-iii-colon-cancer.html

https://www.businesswire.com/news/home/20261008669405/en/Guardant-Health-Announces-Approval-in-Europe-of-Guardant360-CDx-as-Companion-Diagnostic-for-AstraZenecas-ETCAMAH-camizestrant-in-Advanced-ER-positive-Breast-Cancer

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