Bristol Myers (NYSE:BMY) announced that the FDA has accepted its supplemental new drug application (sNDA) for Krazati (adagrasib) in combination with Erbitux (cetuximab) for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA has granted Priority Review status to the company’s sNDA for this combination therapy.
A Priority Review designation accelerates the review period by four months, with a final decision expected on June 21, 2024.
Krazati was initially approved in 2022 for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, under the FDA’s accelerated approval pathway. Continued approval for this indication is subject to the success of Bristol Myers’ confirmatory studies on Krazati.
The company also received conditional marketing authorization in the EU for Krazati as a targeted treatment option for adult patients with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy.
Over the past year, Bristol Myers’ shares have declined by 30.1%, compared with the industry’s 8.6% decrease.
The sNDA submission seeking approval for the Krazati/Erbitux combination therapy for the treatment of CRC is based on positive results from Bristol Myers’ phase I/II KRYSTAL-1 study. This ongoing study is evaluating Krazati as a monotherapy or in combination with other anticancer therapies in patients with advanced solid tumors harboring a KRASG12C mutation.
The primary endpoint for the registrational phase II cohort of the KRYSTAL-1 study was the objective response rate, with secondary endpoints including duration of response, progression-free survival, overall survival, and safety.
Data from the KRYSTAL-1 study showed that Krazati was well tolerated and demonstrated promising clinical activity in pretreated patients with locally advanced or metastatic CRC harboring a KRASG12C mutation. Additionally, the combination of Krazati and Erbitux exhibited a consistent safety profile.
Investors should note that Krazati was added to Bristol Myers’ oncology portfolio following the $4.8 billion acquisition of Mirati Therapeutics, completed in January 2024.
Bristol Myers continues to evaluate Krazati as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumors, including NSCLC and CRC.
Featured Image: Megapixl
Author Stephanie Bédard-Châteauneuf 
