- In December 2024, the Food and Drug Administration (FDA) approved ensartinib (Ensacove, Xcovery Holdings, Inc.) for the treatment of adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not been previously treated with an ALK inhibitor
- In May 2024, Pfizer Inc. announced the long-term follow-up results from the Phase 3 CROWN trial, which evaluated LORBRENA (lorlatinib, a third-generation ALK inhibitor, marketed in Europe as LORVIQUA) compared to XALKORI (crizotinib) in patients with previously untreated ALK-positive advanced non-small cell lung cancer (NSCLC)
- In April 2024, the Food and Drug Administration approved alectinib (Alecensa, Genentech, Inc.) for adjuvant treatment following tumour resection in patients with ALK-positive non-small cell lung cancer (NSCLC), as identified through an FDA-approved test
- In September 2023, Merck and Eisai shared updates on two Phase 3 trials, LEAP-006 and LEAP-008, assessing the combination of KEYTRUDA, Merck's anti-PD-1 therapy, and LENVIMA, the orally available multi-receptor tyrosine kinase inhibitor developed by Eisai, in patients with specific types of metastatic non-small cell lung cancer
- In March 2021, the U.S. Food and Drug Administration (FDA) approved Pfizer Inc.’s supplemental New Drug Application (sNDA) for LORBRENA (lorlatinib), broadening its indication to include first-line treatment for patients with ALK-positive non-small cell lung cancer (NSCLC). LORBRENA is now approved for adults with metastatic NSCLC whose tumors are ALK-positive, as identified by an FDA-approved test
- In January 2021, Takeda Pharmaceutical Company Limited announced that it received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market ALUNBRIG Tablets 30 mg and 90 mg (brigatinib, development code: AP26113) as a first- and second-line treatment for patients with unresectable, advanced, or recurrent ALK fusion gene-positive non-small cell lung cancer (ALK+ NSCLC)
