MedPath

FDA Accepts Nivolumab-Ipilimumab Combination for First-line Treatment of dMMR/MSI-H Colorectal Cancer

• The FDA has accepted the sBLA for nivolumab plus ipilimumab combination therapy as a potential first-line treatment for MSI-H/dMMR colorectal cancer, with a PDUFA date set for June 2025.

• The submission is backed by data from the phase 3 CheckMate 8HW study, offering a potential chemotherapy-free option for both adult and pediatric patients with unresectable or metastatic disease.

• Experts emphasize the importance of early biomarker identification to potentially spare patients from chemotherapy, marking a significant advancement in personalized cancer treatment.

Bristol Myers Squibb's immunotherapy combination has reached a significant milestone in its pursuit to transform the treatment landscape for colorectal cancer patients. The FDA's acceptance of the supplemental Biologics License Application (sBLA) for nivolumab plus ipilimumab marks a potential paradigm shift in first-line treatment options for patients with microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) unresectable or metastatic colorectal cancer.

Clinical Development and Trial Details

The application is supported by data from the phase 3 CheckMate 8HW study, which has been evaluating the efficacy and safety of the nivolumab-ipilimumab combination. This development is particularly noteworthy as it encompasses both adult and pediatric patients aged 12 years and older, addressing an important unmet need in pediatric oncology.
Dr. Mark A. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah, highlighted the study's significance: "CheckMate 8HW has been [ongoing] for several years now as we have gotten updates from the study's maturation, [evaluating] the combination of nivolumab and ipilimumab."

Impact on Treatment Paradigm

The potential approval could represent a significant advancement in the treatment of colorectal cancer, particularly for patients with specific biomarker profiles. Dr. Lewis emphasized the crucial role of early biomarker testing: "It drives home the point of [identifying] biomarkers as early as possible, because if you can save a patient from chemotherapy, that is a wonderful thing to do."

Regulatory Timeline

The FDA has set a Prescription Drug User Fee Act (PDUFA) target date of June 23, 2025, for this indication. This timeline suggests the potential for a new treatment option becoming available to patients within the next year, pending regulatory approval.

Clinical Implications

The development of this immunotherapy combination represents a potential shift away from traditional chemotherapy-based approaches for eligible patients. The focus on biomarker-driven patient selection aligns with the growing trend toward personalized medicine in oncology, potentially offering more targeted and less toxic treatment options for patients with MSI-H/dMMR colorectal cancer.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

BREAKWATER Trial: Braftovi-Erbitux Plus Chemotherapy Shows Promise in BRAF V600E Metastatic Colorectal Cancer

Phase III BREAKWATER trial demonstrates efficacy of first-line combination therapy using Braftovi, Erbitux, and mFOLFOX6 chemotherapy in BRAF V600E mutated metastatic colorectal cancer patients.
The study, led by MD Anderson Cancer Center researchers, represents a significant advancement in targeted therapy approaches for this specific genetic mutation in colorectal cancer.

FDA Approves Zolbetuximab for Gastric and Gastroesophageal Junction Cancer

The FDA has approved zolbetuximab in combination with chemotherapy for patients with HER2-negative, CLDN18.2-positive locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
The approval was based on results from the SPOTLIGHT and GLOW trials, which demonstrated statistically significant improvements in progression-free survival and overall survival.

Oncolytics Biotech and Bio-Path Holdings Announce Promising Cancer Therapy Advancements

Oncolytics Biotech presented data at the ASCO GI Symposium, highlighting pelareorep's potential in treating relapsed anal and metastatic pancreatic cancers.
A GOBLET study cohort showed a 33% objective response rate in relapsed anal cancer patients treated with pelareorep and atezolizumab, including a complete response lasting over 15 months.

FDA Updates: Approvals and Designations in Leukemia, Prostate Cancer, and Melanoma

Capivasertib plus abiraterone and ADT shows improved radiographic progression-free survival in PTEN-deficient metastatic hormone-sensitive prostate cancer.
LBS-007 receives FDA fast track designation for acute myeloid leukemia treatment based on promising early response data from a phase 1/2 trial.

Recent Clinical Trial Updates and FDA Actions in Oncology: A Review

The VERONA and SELECT-MDS-1 trials are evaluating novel combinations in myelodysplastic syndromes (MDS) that could potentially shift the treatment paradigm.
Enhertu (fam-trastuzumab deruxtecan-nxki) has received priority review from the FDA for HER2-low/ultra-low breast cancer, showing promise as a targeted treatment option.

Trump Administration Reshapes Health Agencies; FDA Approves Novel Cancer Therapies

President-elect Trump nominates Robert F. Kennedy Jr. as HHS Secretary, Mehmet Oz to lead CMS, and Marty Makary to head the FDA, signaling a shift in healthcare priorities.
The FDA grants accelerated approval to asciminib for chronic myeloid leukemia and obecabtagene autoleucel for B-cell acute lymphoblastic leukemia, marking advancements in cancer treatment.

FDA Actions in October 2024 Accelerate Oncology Treatment Advances

The FDA granted priority review to fam-trastuzumab deruxtecan-nxki (T-DXd) for HER2-low/ultra-low breast cancer, potentially expanding treatment options for this patient subgroup.
Acalabrutinib (Calquence) was approved for frontline mantle cell lymphoma (MCL), offering a new first-line treatment option for patients with this aggressive lymphoma.

Advancements in Oncology: CAR-T Therapy for Myeloma, Cologuard Plus Approval, and NSCLC Treatment

HBI0101, a novel BCMA-directed CAR T-cell therapy, shows high efficacy and manageable safety in relapsed/refractory multiple myeloma patients, offering a promising treatment option.
Cologuard Plus receives FDA approval as a noninvasive stool DNA test for colorectal cancer screening in adults 45 and older, demonstrating improved detection rates.

NKT2152 Shows Promise in Advanced Renal Cell Carcinoma

NKT2152, a novel oral HIF2α inhibitor, demonstrates encouraging objective response rates (ORR) in pretreated advanced clear cell renal cell carcinoma (RCC) patients.
The phase 1/2 study (NCT05119335) involving 100 RCC patients presented at the 2024 ESMO Congress, highlights NKT2152's robust antitumor activity.

FDA's July Roundup: Approvals, Fast Tracks, and Designations in Oncology

The FDA approved FoundationOne Liquid CDx as a companion diagnostic for niraparib and abiraterone in BRCA-mutated metastatic castration-resistant prostate cancer.
Several therapies received fast track designations, including OBX-115 for advanced melanoma and ADI-270 for metastatic clear cell renal cell carcinoma.

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy