BRIGANIX (generic name: brigatinib) is a medication indicated for the treatment of patients diagnosed with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have either progressed on or are intolerant to crizotinib, another medication used in the treatment of ALK-positive NSCLC.

The approval for this indication is based on accelerated approval criteria, which means that it was granted based on evidence of its effectiveness in terms of tumor response rate and duration of response. Accelerated approval allows for the expedited availability of promising drugs for serious conditions based on surrogate endpoints such as tumor response rate, with the understanding that further confirmation of clinical benefit is needed through ongoing confirmatory trials.

The clinical trials supporting the approval of BRIGANIX likely demonstrated its ability to shrink tumors and/or delay tumor growth in patients with ALK-positive metastatic NSCLC who have previously received crizotinib therapy. The duration of response refers to the length of time during which patients experience either complete or partial shrinkage of their tumors in response to treatment with BRIGANIX.

It’s important to note that while accelerated approval allows for earlier access to potentially beneficial medications, continued approval for this indication depends on the results of ongoing confirmatory trials. These trials are conducted to further evaluate the clinical benefit of BRIGANIX, such as overall survival, progression-free survival, and quality of life outcomes, which are considered more direct measures of a drug’s effectiveness in treating a particular condition.

Patients prescribed BRIGANIX should be monitored closely for any adverse reactions or side effects, and healthcare providers should discuss the potential risks and benefits of treatment with their patients. Additionally, patients should be informed about the need for ongoing participation in clinical trials if applicable, as well as any updates regarding the drug’s approval status and available treatment options.