New Colon Cancer Approval + FDA Breakthrough Designations - Oncology Updates
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://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://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.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 (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)
📲 Oncology at your fingertips.
Access the ONCOassist app:
📥 iOS, Android & Webapp: https://campaign.oncoassist.com/social-y (https://campaign.oncoassist.com/social-y)
1 Oct 2026
New FDA Breast & Kidney Cancer Approvals + Phase III Data - Oncology Updates
New FDA approvals and practice-relevant Phase III 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:
🔹 ER+/HER2− Breast Cancer: The FDA approved Imlunestrant plus Abemaciclib for adults with ESR1-mutated advanced or metastatic breast cancer following progression after prior endocrine therapy. In Phase III EMBER-3, median PFS was 11.1 months with the combination versus 5.5 months with imlunestrant alone (HR 0.53).
🔹 EGFR-Mutated NSCLC: Phase III ADVANCE evaluated a chemotherapy-free strategy of aumolertinib plus radiotherapy versus concurrent chemoradiotherapy in unresectable Stage III EGFR-mutated NSCLC. Median PFS was 34 months versus 7.4 months (HR 0.15), although the randomized population included only 43 patients and overall survival remains immature.
🔹 Biliary Tract Cancer: Five-year follow-up from Phase III ASCOT confirmed a sustained survival benefit with adjuvant S-1 following resection. Five-year OS was 64% with S-1 versus 52% with observation (HR 0.72), with median OS of 8.2 versus 5.9 years.
🔹 Advanced Renal Cell Carcinoma: The FDA approved Belzutifan plus Lenvatinib for adults with advanced RCC with a clear cell component following prior PD-1 or PD-L1 inhibitor therapy. The approval was based on LITESPARK-011, which enrolled 747 patients.
Reference Links:
https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-combination-verzenio (https://investor.lilly.com/news-releases/news-release-details/us-fda-approves-inluriyo-imlunestrant-combination-verzenio)https://www.nature.com/articles/s41392-026-02891-2 (https://www.nature.com/articles/s41392-026-02891-2) https://ascopubs.org/doi/10.1200/JCO-26-00017 (https://ascopubs.org/doi/10.1200/JCO-26-00017) https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-combination-lenvatinib-advanced-renal-cell-carcinoma-clear-cell-component (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-combination-lenvatinib-advanced-renal-cell-carcinoma-clear-cell-component)
📲 Oncology at your fingertips.
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📥 iOS, Android & Webapp: https://campaign.oncoassist.com/social-y (https://campaign.oncoassist.com/social-y)
17 Sept 2026
Oncology News: Trastuzumab deruxtecan EU Approval, Sevabertinib & Major Phase III Cancer Data
🎥 Latest Oncology News
Four developments across breast cancer, lung cancer, multiple myeloma and prostate cancer.
In this episode of Oncology Updates from ONCOassist, Dr. Stephanie Haddad reviews:
🔹 HER2+ metastatic breast cancer: The European Commission has approved Enhertu (Trastuzumab deruxtecan) plus Pertuzumab as first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. In Phase III DESTINY-Breast09, the combination reduced the risk of disease progression or death by 44% versus THP, with median PFS of 40.7 vs 26.9 months.
🔹 Relapsed/refractory multiple myeloma: Phase III CERVINO topline results showed an ORR of 74.0% with investigational Etentamig versus 45.7% with standard available therapies, alongside a 60% reduction in the risk of progression or death.
🔹 Prostate cancer: The randomized STAMINA trial evaluated a 12-month supervised programme combining exercise, dietary advice and behavioural support for men receiving androgen deprivation therapy. Dr. Haddad reviews its reported effects on prostate cancer-specific quality of life, fatigue and overall cancer-related quality of life.
🔹 HER2-mutated NSCLC: The FDA granted accelerated approval to Sevabertinib for adults with locally advanced or metastatic non-squamous NSCLC harbouring HER2/ERBB2 activating mutations, based on response rate and duration-of-response data from SOHO-01.
Reference Links:
https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-approved-in-eu-for-1l-her2-positive-mbc.html (https://www.astrazeneca.com/media-centre/press-releases/2026/enhertu-approved-in-eu-for-1l-her2-positive-mbc.html)
https://news.abbvie.com/2026-09-03-AbbVie-Announces-Positive-Topline-Results-from-the-Phase-3-CERVINO-Trial-Showing-Etentamig-Significantly-Improved-Response-Rate-and-Progression-Free-Survival-in-Patients-with-Relapsed-Refractory-Multiple-Myeloma (https://news.abbvie.com/2026-09-03-AbbVie-Announces-Positive-Topline-Results-from-the-Phase-3-CERVINO-Trial-Showing-Etentamig-Significantly-Improved-Response-Rate-and-Progression-Free-Survival-in-Patients-with-Relapsed-Refractory-Multiple-Myeloma)
https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(26)00304-9/fulltext (https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(26)00304-9/fulltext)
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small)
📲 Oncology at your fingertips.
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📥 iOS, Android & Webapp: https://campaign.oncoassist.com/social-y
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