Skip to main content

Talk Bio

Search This Blog

Bristol lays out KRAS med Krazati's stumble in confirmatory colorectal cancer trial

on July 07, 2026

Get link
Facebook
X
Pinterest
Email
Other Apps

Krazati has failed its confirmatory study in second-line colorectal cancer after receiving accelerated approval in 2024.

Bristol Myers Squibb has ended the Krazati Phase III confirmatory trial in KRAS G12C-mutant colorectal cancer as it failed to meet its primary endpoint.

Krazati (adagrasib) in combination with cetuximab remains FDA-accelerated approved for previously treated KRAS G12C-mutated metastatic colorectal cancer based on earlier KRYSTAL-1 data.

The failure in the confirmatory trial raises questions about Krazati’s long-term regulatory status in colorectal cancer despite its earlier promising phase 1/2 data.

Sources:

BMS gets FDA approval for Krazati in colorectal cancer

KRAZATI (adagrasib) in Combination with Cetuximab Demonstrates ...

Bristol Myers Squibb Announces U.S. FDA Accelerated ...

Krazati fails confirmatory trial in colorectal cancer ... - Endpoints News

Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic...

Mirati announces Adagrasib (KRAZATI™) Receives Breakthrough Therapy Designation from FDA for Patients with Advanced, KRAS-Mutated Colorectal Cancer and NEJM Publishes Phase 1b/2 Data from Adagrasib With or Without Cetuximab in Colorectal Cancer

Bristol Myers pulls KRAS cancer trial | Endpoints News posted on ...

FDA Approves First Colorectal Cancer Treatment that Targets G12C ...

Bristol bids to outdo Amgen in KRAS | ApexOnco

BMS expands Krazati's FDA label to include colorectal cancer

Bristol Myers says KRAS drug succeeds in key trial - BioPharma Dive

Adagrasib in the treatment of colorectal cancer - PMC - NIH

BMS touts KRAS confirmatory trial win after Amgen's stumble

Accelerated adagrasib Approved Colorectal Carcinoma Confirmatory Trial KRAS NP_004976.2:p.G12C Krazati KRAZATI-12 KRYSTAL-1 Myers Squibb Phase 3 United States Food and Drug Administration

Get link
Facebook
X
Pinterest
Email
Other Apps

Popular Posts

KOL Bulletin: Brilaroxazine's Potential Differentiation on EPS Over Risperidone in Schizophrenia

A leading US KOL states that brilaroxazine shows placebo-like extrapyramidal symptoms (EPS) at week 4, potentially differentiating it from risperidone which cannot achieve this 1 . Reviva plans to initiate the RECOVER-2 Phase 3 trial for brilaroxazine in schizophrenia in H1 2026 following FDA recommendation for additional efficacy and safety data 2 . Brilaroxazine demonstrates broad-spectrum efficacy across schizophrenia symptom domains, including negative symptoms, with a well-tolerated safety profile in over 900 subjects 2 4 . Phase 3 RECOVER trial data shows low EPS and akathisia, mild weight gain (1.52 kg pooled), reductions in prolactin levels, and improvements in sexual function over 1 year 4 . New publication highlights speech latency as an objective vocal biomarker for brilaroxazine's effect on negative symptoms, reinforcing efficacy 3 5 . Sources: 1. https://firstwordhealthtech.com 2. https://www.biospace.com/press-releases/reviva-announces-regulatory-update-...

Ultragenyx Resubmits BLA for UX111 Gene Therapy with New Long-Term Data for Sanfilippo Syndrome Type A

Ultragenyx resubmitted its Biologics License Application (BLA) to the FDA for UX111, an AAV9 gene therapy for Sanfilippo syndrome type A (MPS IIIA), including long-term clinical data on neurologic, biomarker, and safety improvements. 1 2 3 4 5 The resubmission addresses a Complete Response Letter from July 2025 related to manufacturing (CMC) observations and adds durable biomarker reductions, such as CSF heparan sulfate, with favorable safety profile. 2 4 5 FDA's six-month priority review has begun; PDUFA action date expected in Q3 2026. 2 4 5 If approved, UX111 would be the first therapy for this fatal pediatric neurodegenerative disorder. 1 3 4 5 New long-term data announced February 3, 2026, shows substantial biomarker improvements and functional benefits vs. natural history, consistent across age and severity. 2 Sources: 1. https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-rare/ultragenyx-pharmaceutical/news/ultragenyx-bla-resubmission-puts-ux111-and-ra...

Pfizer's Monthly GLP-1 Data from VESPER-3: Competitive Weight Loss Validates $10B Metsera Acquisition

Pfizer's Phase 2b VESPER-3 trial of ultra-long-acting GLP-1 RA PF-08653944 (MET-097i) achieved up to 12.3% placebo-adjusted weight loss at 28 weeks with monthly maintenance dosing after initial weekly titration 1 3 4 . Weight loss continued robustly post-switch to monthly dosing with no plateau observed at week 28, supporting Phase 3 advancement including higher 9.6 mg dose 1 3 . Data described as competitive with rivals (9-13% at week 28), validating Pfizer's $10B Metsera acquisition, with 10 Phase 3 trials planned for 2026 1 3 2 . Tolerability profile favorable with mostly mild/moderate GI events; full VESPER-3 data to be presented June 2026 1 3 . Analysts view results as encouraging but note questions on placebo benefits, discontinuations, and comparison to prior weekly data 3 5 . Sources: 1. https://www.pfizer.com/news/press-release/press-release-detail/pfizers-ultra-long-acting-injectable-glp-1-ra-shows-robust 2. https://www.pharmaceutical-technology.com/anal...

Powered by Blogger

X-Data LLC