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news.The US Food and Drug Administration (FDA) has approved Pfizer’s Xalkori (crizotinib) capsules as a treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC).
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The FDA approval is based on data from 255 patients with locally advanced or metastatic ALK-positive NSCLC across 2 multi-center, single-arm studies, including a Phase 2 study (Profile 1005) and a Part 2 expansion cohort of a Phase 1 study (Study 1001).
The primary efficacy endpoint in both studies was objective response rate (ORR) according to response evaluation criteria in solid tumors (RECIST).
In Profile 1005 (n=136), based on investigator assessments, the ORR was 50%, including one complete response and 67 partial responses.
Seventy-nine percent of objective tumor responses were achieved during the first 8 weeks of treatment.
In Study 1001 (n=119), based on investigator assessments, the ORR was 61%, including two complete responses and 69 partial responses.
Fifty-five percent of objective tumor responses were achieved during the first 8 weeks of treatment.
Pfizer worked closely with the FDA and partnered with Abbott Molecular’s business in Pfizer’s clinical studies to ensure the simultaneous review and approval of Xalkori along with a diagnostic test, Abbott Molecular’s Vysis ALK Break Apart FISH Probe Kit, to identify presence of the ALK fusion gene.
The simultaneous approval of Xalkori in parallel with Abbott Molecular’s ALK FISH Test marks the first time a Pfizer oncology drug or any lung cancer medication was developed and approved in parallel with a diagnostic test.