BMS gets speedy FDA review for KRAS inhibitorKRAS inhibitor in colorectal cancer

20 Feb 2024
Drug ApprovalPriority ReviewAcquisitionAccelerated Approval
More than two years after data were first unveiled for Krazati (adagrasib) in colorectal cancer, the oral KRAS inhibitorKRAS inhibitor – now in the hands of Bristol Myers Squibb – has been accepted for review by the FDA. The agency is set to make a decision on the application by June 21, having granted the filing priority assessment.
The submission is based on results from the Phase I/II KRYSTAL-1 study, which included a cohort of pretreated colorectal cancer patients with locally advanced or metastatic disease harbouring a KRASG12C mutation. Data at the time showed that based on 45 evaluable patients, the overall response rate was 22%, including one unconfirmed partial response, while the disease-control rate was 87%.
Bristol Myers Squibb’s filing is seeking approval of Krazati in combination with cetuximab for the treatment of patients with previously treated KRASG12C-mutated locally advanced or metastatic colorectal cancer. The drug is already authorised in the US under the accelerated approval pathway for the treatment of adults with KRASG12C-mutated locally advanced or metastatic non-small-cell lung cancer (NSCLC).
Krazati came into Bristol Myers Squibb’s portfolio via the $5.8-billion purchase of Mirati Therapeutics last month. Shortly before the transaction was completed, the European Commission granted conditional approval to the drug for adults with KRASG12C-mutated advanced NSCLC and disease progression after at least one prior systemic therapy.
At one point, clearance in Europe had seemed a longshot after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion, partly due to the availability of Amgen's competing KRAS drug Lumykras (sotorasib). However, following a reassessment, the CHMP determined that questionable survival data from Amgen’s CodeBreaK 200 study of Lumykras were “not necessarily relevant” to Krazati.
For related analysis, read Vital Signs: Do KRAS blunders weigh down targeted therapy in lung cancer?
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