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东盟制药

Lorlatinib 25mg

Lorlatinib 25mg

¥450.00 CNY
¥450.00 CNY
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Lorlatinib was officially approved by the U.S. FDA on November 2 , 2018 for the treatment of anaplastic lymphoma kinase (ALK) -positive metastatic non-small cell lung cancer (NSCLC) . As a new, reversible, potent small molecule ALK and ROS1 inhibitor , lorlatinib has a strong inhibitory effect on known ALK resistance mutations, and is therefore known as the "third-generation ALK inhibitor."

Lorlatinib is effective against lung cancer that is resistant to crizotinib and second-generation ALK inhibitors. Moreover, due to its high blood-brain barrier permeability, it can exert a better effect on non-small cell lung cancer with central nervous system metastasis. It is suitable for the treatment of ALK-positive and ROS1-positive advanced NSCLC. Based on this, the FDA has granted it breakthrough therapy and orphan drug status.


As a new generation of ALK inhibitor, the advantage of Lorlatinib is that after patients have developed drug resistance after receiving multiple other ALK inhibitors, Lorlatinib may still be effective and can greatly prolong the patient's survival.
 
The approval was mainly based on data from a Phase II clinical trial that evaluated the efficacy of patients treated in different cohorts. The Phase II clinical trial included 275 patients with ALK+ or ROS1+ advanced NSCLC, most of whom had brain metastases and had been treated with ALK drugs or even chemotherapy. They were treated with lorlatinib 100 mg qd and the overall ORR and ORR of brain lesions were analyzed.

The test results show that:
a) For 30 ALK-positive patients who were newly diagnosed, lorlatinib was used directly as the first-line treatment: 27 patients had significantly reduced tumors, with an effective rate of 90% and an overall intracranial response rate of 75%; 2 patients had stable tumors without progression, with a disease control rate of 97%; only one patient had no effect.
b) For 59 patients who had used crizotinib or crizotinib + chemotherapy, the efficacy of lorlatinib as a second-line or third-line drug was still as high as 69%, and the total intracranial response rate was 68%.
c) For patients who have used 2-3 ALK inhibitors in addition to chemotherapy, lorlatinib is used as a third-line or even fifth-line drug, and its efficacy is still 39%.


Specifications

Indications: Patients with ALK-positive lung cancer whose disease has progressed after treatment with crizotinib or at least one other ALK inhibitor, or after treatment with alectinib or ceritinib as the first ALK inhibitor.

Dosage: Take 100 mg orally once a day at the same time every day. If you forget to take it, you can take it as soon as it is less than 4 hours before the next use. Do not take two doses at the same time.

Side effects: Swelling of the arms, legs, hands, and feet (edema); numbness and tingling feelings in the joints or arms and legs (peripheral neuropathy); trouble thinking or confusion; trouble breathing; fatigue; weight gain; joint pain; mood changes; feeling sad or anxious; diarrhea, etc.

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