Bristol Myers’ SNDA for Krazati and Cetuximab Gets Approval

US FDA accepts for priority review Bristol Myers’ sNDA for Krazati in combo with cetuximab for patients with previously treated KRAS G12C-mutated locally advanced or metastatic CRC

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has accepted for priority review the supplemental new drug application (sNDA) for Krazati (adagrasib) in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024.

Words from Bristol Myers Squibb

Pretreated KRASG12C-mutated CRC is associated with poor outcomes and the current standard of care offers limited clinical benefit for patients,” said Anne Kerber, senior vice president, head of late clinical development, haematology, oncology, cell therapy (HOCT) at Bristol Myers Squibb. “The acceptance of this filing for Krazati in combination with cetuximab is a positive step toward providing a potential new option for patients and their physicians. It reinforces our commitment to developing potentially transformative targeted cancer therapies for patients for whom few treatment options exist.

Trials Behind Submission

• The submission is based on the results of KRYSTAL-1 study, a multicohort trial which evaluated Krazati alone or in combination with other anticancer therapies in patients with advanced solid tumours harbouring a KRASG12C mutation. 

• The primary endpoint for the registrational cohort was objective response rate. 

• The secondary endpoints for the pooled cohorts included duration of response, progression-free survival, overall survival and safety.

• Results of the KRYSTAL-1 study showed that Krazati was well tolerated and provided promising clinical activity in pretreated patients with locally advanced or metastatic CRC harboring a KRASG12C mutation. 

• The safety profile for Krazati plus cetuximab was manageable and consistent with previous reports, and with the known safety profile of each drug individually.

About Krazati

• Krazati (adagrasib) is highly selective and potent oral small-molecule inhibitor of KRASG12C that is optimized to sustain target inhibition, an attribute that could be important to treat KRASG12C-mutated cancers, as the KRASG12C protein regenerates every 24-48 hours. 

• KRASG12C mutations act as oncogenic drivers and occur in approximately 14% of NSCLC (adenocarcinoma), 3-4% of colorectal cancer, and 1-2% of several other cancers.

• In 2022, Krazati was granted accelerated approval for treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. 

• This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). 

• Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

• Additional marketing authorization:- In 2024, the European Commission (EC) granted conditional marketing authorization 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.

• Krazati continues to be evaluated as monotherapy and in combination with other anti-cancer therapies in patients with advanced KRASG12C-mutated solid tumours, including NSCLC and colorectal cancer.

BTD for Krazati

In 2022, the FDA granted breakthrough therapy designation for Krazati in combination with cetuximab in patients with KRASG12C-mutated advanced colorectal cancer (CRC) whose cancer has progressed following prior treatment with chemotherapy and an anti-VEGF therapy.

About KRYSTAL-1

• KRYSTAL-1 is an open-label, multicenter, multiple expansion cohort phase 1/2 trial to determine the safety and efficacy of Krazati in patients with advanced solid tumours that harbour a KRASG12C mutation. 

• The primary endpoint for the phase 2 cohort of the KRYSTAL-1 study was objective response rate. 

• Secondary endpoints included duration of response, progression-free survival, overall survival and safety.

Krazati Indications 

• Krazati is indicated for the treatment of adult patients with KRASG12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy.

• This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). 

• Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial(s).

About Colorectal Cancer

Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. CRC is the third most commonly diagnosed cancer in the world. In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease; it is the second leading cause of cancer-related deaths among men and women combined.

Bristol Myers Squibb: Their Vision

• Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. 

• Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine and, through innovative digital platforms, are turning data into insights that sharpen their focus. 

• Deep understanding of causal human biology, cutting-edge capabilities and differentiated research platforms uniquely position the company to approach cancer from every angle.

Bristol Myers Squibb’s Aims for Cancer

Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. As a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

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