Crizotinib (Xalkori) is accepted for use within NHS Scotland...treatment of adults with ROS1 positive advanced non-small cell lung cancer (NSCLC).

XALKORI is a kinase inhibitor indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test

...Pfizer Canada announced that Health Canada has expanded the indication of XALKORI® (crizotinib) to include its use as a monotherapy in the treatment of patients with ROS1-positive locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC).

Crizotinib is recommended in the first-line setting in patients with stage IV NSCLC with ROS1 rearrangement…

The NCCN NSCLC Panel recommends crizotinib, entrectinib, or ceritinib (all are category 2A) as first-line therapy options for patients with ROS1-positive metastatic NSCLC…

Pfizer Inc. announced today that XALKORI (crizotinib) received Breakthrough Therapy designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).

...Positive for translocation or inversion events involving the ROS1 gene...

In this phase 2, open-label, single-arm trial, East Asian patients with ROS1-positive advanced NSCLC who had received ≤3 prior systemic therapies were treated with crizotinib 250 mg twice daily...the median OS was 44.2 months (95% CI: 32.0–not reached) for the total population (N = 127).

A total of 64 ROS1+ patients included in the METROS trial...At a median follow-up >4 years, crizotinib confirmed its marked activity in ROS1+ NSCLC. Risk of disease progression and death was higher in patients with BM, highlighting the need for brain-penetrant drugs in the management of ROS1+NSCLC.

Data for patients diagnosed of ROS-1 or ALK positive NSCLC with distant metastases were retrospectively collected in our center….For patients who received crizotinib as initial ROS-1 or ALK inhibitors(ROS-1:n=36, ALK:n=36), ROS-1+ NSCLC demonstrated more favorable PFS compared with their counterparts(16.5m vs 10.5m, p<0.001,HR=0.39, 95%CI: 0.23 to 0.67); CNS-TTP was also found to be significantly longer in ROS-1+ NSCLC( for patients with baseline CNS lesion...

The study cohort included 38 ROS1-positive patients treated with crizotinib….The median TTD, TTNT, and OS were 25.2 months [95% confidence interval (CI): 5.2–not reached (NR)], 25.0 months (95% CI 5.2–61.0), and 36.2 months (95% CI 15.9–NR), respectively...our findings support the clinical benefit of crizotinib in this patient population with ROS1-positive advanced NSCLC.

73 patients were included: 51 patients ALK+, 22 patients ROS1+....Objective Response Rate for ALK+ and ROS1+ was 62.7% and 55% respectively. Median progression-free survival (IC95) was ALK+ 9.4 months (7-16.1) and ROS1+ 6.6 months (4.3-14.3) median Overall Survival (IC95)....Crizotinib was effective in both ALK+ and ROS1+ aNSCLC in a real-life setting with no new safety concerns.

In this phase 2, open-label, single-arm trial, East Asian patients with ROS1+ NSCLC who had received ≤3 prior systemic therapies were treated with crizotinib 250 mg BID on a continuous daily dosing schedule in 28-day cycles….median duration of follow-up for OS was 56.1 months. Median OS was 44.2 months (95% CI: 32.0, not reached [NR]) for the total population, 31.2 months (95% CI: 14.8, NR) for Japanese patients (n=26), 48.5 months (95% CI: 32.8, NR) for Chinese patients (n=74), and 43.7 months (95% CI: 21.7, NR) for other patients (n=27).

We evaluated the data of twenty-one ROS1 positive metastatic NSCLC patients treated with crizotinib...Disease control ratio (partial response-55.6%, stable response-27.8%) was 83.4%. Median progression-free survival was 26.1 (95% CI, 8.1–44.1) months.

The study cohort included 38 patients diagnosed with ROS1-positive advanced NSCLC who received crizotinib...The median OS was 36.2 months (95% CI: 15.9, NR), and survival probabilities at 12, 24, 36 and 48 months were 71.9%, 64.9%, 60.5%, and 26.9%, respectively.

Among patients with ROS1-positive NSCLC, crizotinib exhibited a pooled DCR of 93.2% (95% confidence interval [CI] 90.8-95.5) and a pooled ORR of 77.4% (95% CI 72.8-82.1). The median progression-free survival (PFS) and overall survival (OS) of patients in this group was 14.5 and 32.6 months, respectively.

This phase II, open-label, single-arm trial enrolled East Asian patients with ROS1-positive (assessed through validated AmoyDx assay [Amoy Diagnostics, Xiamen, China] at three regional laboratories) advanced NSCLC...The primary end point was objective response rate (ORR) by IRR. Results In the efficacy and safety analyses, 127 patients were included, with 49.6% still receiving treatment at data cutoff. ORR by IRR was 71.7% (95% CI, 63.0% to 79.3%), with 17 complete responses and 74 partial responses. ORRs were similar irrespective of the number of prior lines of therapy, and responses were durable (median duration of response, 19.7 months; 95% CI, 14.1 months to not reached). Median progression-free survival by IRR was 15.9 months (95% CI, 12.9 to 24.0 months).

Fifty-three patients received crizotinib, with a median duration of treatment of 22.4 months. At data cut-off, treatment was ongoing in 12 patients (23%). The objective response rate (ORR) was 72% [95% confidence interval (CI), 58% to 83%], including six confirmed complete responses and 32 confirmed partial responses; 10 patients had stable disease. Responses were durable (median duration of response 24.7 months; 95% CI, 15.2–45.3)....phase I PROFILE 1001 study, crizotinib showed antitumor activity in patients with ROS1 rearranged advanced non-small-cell lung cancer (NSCLC).

This study examined the case of a patient with ROS1-positive recurrent non-small-cell lung cancer treated with crizotinib and traditional Korean medicine….The patient was treated with crizotinib from January 20 2021 to May 22 2021....After four months of combined treatment, the sizes of the lymph nodes in the porta hepatis, hepatoduodenal, retrocrural, aortocaval, and para-aortic areas had decreased, and no lymph nodes larger than 1 cm in diameter were observed.