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FDA Grants Brigatinib Accelerated Approval for NSCLC, Giving New Hope to Lung Cancer, Mesothelioma Patients

A drug that was previously granted both Breakthrough Therapy Designation and Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) has now been granted accelerated approval by the agency. Per the National Cancer Institute (NCI), the drug, brigatinib (Alunbrig), is now approved for patients with metastatic non-small cell lung cancer (NSCLC) and alterations in the anaplastic lymphoma kinase (ALK) gene “whose cancer has progressed during their initial therapy.” Currently, “patients with metastatic ALK-positive NSCLC receive the targeted drug crizotinib (Xalkori) as their initial or first-line treatment. Two other drugs that target ALK, ceritinib (Zykadia) and alectinib (Alecensa), are approved for use in patients whose tumors have stopped responding to crizotinib” says NCI.

Under the accelerated approval, ALK-positive patients who are no longer responding to or cannot tolerate crizotinib may be treated with brigatinib. “The approval makes brigatinib the fourth ALK-targeted drug to be approved by FDA and the third for use after treatment with crizotinib.”

Brigatinib is an inhibitor of receptor tyrosine kinases ALK and the epidermal growth factor receptor (EGFR) with potential antineoplastic activity. Taken orally, the drug binds to and inhibits ALK kinase and ALK fusion proteins as well as EGFR and mutant forms. This leads to the inhibition of ALK kinase and EGFR kinase, disrupts their signaling pathways, and eventually inhibits tumor cell growth in susceptible tumor cells. In addition, brigatinib appears to overcome mutation-based resistance.

In a phase 2 clinical trial known as ALTA, “222 patients with NSCLC whose tumors had progressed while receiving crizotinib were randomly assigned to treatment with one of two doses of brigatinib (90 or 180 milligrams daily).” Results showed tumor shrinkage in roughly half of participants. The median duration of this tumor response was approximately 14 months. Approval of brigatinib was based on these results.

Though the FDA requires additional studies to confirm overall survival, improved quality of life, and other clinical benefits, for now, brigatinib is available to NSCLC patients. A phase 3 clinical trial is already underway, however, and researchers anticipate that it will confirm all observed clinical benefits. Once this happens, brigatinib will be granted traditional approval by the FDA.

“Now we have an additional second choice,” said Wallace Akerley, M.D., of the Huntsman Cancer Institute at the University of Utah, “it gives us more options, but we do not yet have a way to decide which of the drugs available to us should [ideally] be given first, second, or third.”

So what does this mean for mesothelioma patients? Lung cancer and mesothelioma patients often receive similar treatment protocols, so when a lung cancer drug receives FDA approval, mesothelioma researchers stand up and take notice. With traditional approval for brigatinib for NSCLC patients on the horizon, approval for the treatment of mesothelioma may not be too far behind.

If you have been diagnosed with mesothelioma, talk to your doctor about progressive treatments such as brigatinib. Other clinical trials for treatments such as these could be in the pipeline, currently recruiting, or well underway.

 

Sources

"Approved Drugs - Brigatinib." U.S. Food and Drug Administration (FDA). Center for Drug Evaluation and Research, 28 Apr. 2017. Web. 07 Aug. 2017.

"FDA Grants Accelerated Approval to Brigatinib and Breakthrough Therapy Designation to Lorlatinib." ESMO. European Society for Medical Oncology (ESMO), 02 May 2017. Web. 07 Aug. 2017.

Nair, Abhi, and Sanjeeve Bala, prods. "Two Approvals for ALK-positive Non-small Cell Lung Cancer." Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.). FDA D.I.S.C.O. FDA’s Oncology Center of Excellence, Silver Spring, Maryland, 25 July 2017. U.S. Food & Drug Administration (FDA), Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.). Web. 07 Aug. 2017. Transcript.

"NCI Drug Dictionary - Brigatinib." National Cancer Institute (NCI). U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), 2017. Web. 07 Aug. 2017.

Staudt, M.D., Ph.D., Louis. "Brigatinib Approved by FDA for Lung Cancer." National Cancer Institute (NCI). U.S. Department of Health and Human Services (HHS), National Institutes of Health (NIH), 19 May 2017. Web. 07 Aug. 2017.