Bristol Myers' (BMY) Krazati Gets FDA Nod for Colorectal Cancer [Yahoo! Finance]
Bristol-Myers Squibb Company (BMY)
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Source: Yahoo! Finance
The FDA granted accelerated approval to Krazati, in combination with Erbitux (cetuximab), as a targeted treatment option for adult patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer (CRC). The FDA's approval for this indication was on an accelerated basis, based on objective response rate (ORR) and duration of response (DOR) results. Continued approval for this indication may be contingent upon verification and description of a clinical benefit in a confirmatory trial. The approval is based on positive results from cohorts of the open-label phase I/II KRYSTAL-1 study, wherein Krazati, in combination with Erbitux, showed an ORR of 34% in pretreated patients with locally advanced or metastatic CRC harboring a KRASG12C mutation. The median DOR, one of the secondary endpoints, was 5.8 months. The FDA had granted breakthrough therapy designation to Krazati, in combination with Erbitux, for patients with KRASG12C-mutated advanced CRC whose cancer has prog
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