FDA approves Pfizer's third-generation APK inhibitor for listing

On November 3rd Pfizer announced that the FDA had approved the launch of the third generation of ALC Tyrosine kinase inhibitor (TKI) Lorlatinib for the treatment of ALC-positive metastasis non-small cell lung cancer (NSCLC) patients. The disease continued to worsen after these patients were treated with crizotinib or at least one other ALK inhibitor, or after receiving altinib or ceritinib as the first ALK inhibitor therapy. This is Pfizer's third cancer treatment approved by the FDA in the last two months.
lung cancer is one of the leading causes of cancer death in the world. More people die each year from lung cancer than from colon, breast and prostate cancers. Lung cancer is divided into small cell lung cancer and NSCLC. NSCLC is the most common type of lung cancer, accounting for about 85% of all lung cancer patients. Although many ALC-positive metastasis NSCLC patients respond to the initial TKI therapy, their tumors usually worsen again. Also, for patients who have been treated with second-generation APK TKI but continue to get worse, their treatment options are very limited.
Lorbrena is Pfizer's third-generation ALK TKI. It showed high activity in preclinical lung cancer model trials on tumors carrying the APK and ROS1 dyed weight groups. Lorbrena inhibits tumor mutations that are resistant to other APK inhibitors and can cross the blood-brain barrier. The drug has been approved by the FDA as a breakthrough therapy, and new drug applications have been eligible for priority review.
approval is based on a non-randomized, incremental dose, multi-queue, multi-center Phase 1/2 clinical study. In the trial, called B7461001, 215 ALC-positive metastasis NSCLC patients were treated. The total remission rate (ORR) for patients was 48% (95% CI: 42%, 55%). Importantly, 57% of patients have been treated with more than one ALK TKI. In this trial, 69% of patients had a history of brain metastasis and intracranial remission rates reached 60% (95% CI 49%, 70%). As an expedited approval, Pfizer will continue to conduct validated clinical trials.
Based on our understanding of tumor complexity and therapeutic resistance, Lorbrena was discovered by Pfizer scientists and developed specifically to inhibit tumor mutations that are resistant to other APK TKI," said Andy Schmeltz, Pfizer Global President of Oncology. (Bio Valley)