Brigatinib has received breakthrough designation from the US Food and Drug Administration (FDA), and ARIAD recently commenced submission of a New Drug Application for initial approval in patients who have experienced crizotinib failure. In June, the FDA cleared brigatinib for an Expanded Access Program (EAP), also called “compassionate use,” a special program allowing manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in another clinical trial. The EAP for brigatinib will provide the drug candidate to patients who have experienced failure of at least one prior ALK inhibitor, who cannot meet eligibility criteria for other trials due to a variety of reasons such as poor performance status, lack of geographic proximity, or because other medical interventions are not considered appropriate or acceptable.

“Lung cancer is the leading cause of cancer-related deaths in the United States and is extremely difficult to treat because there are so many different mutations,” explained Raymond Wadlow, M.D., medical oncologist and co-director of the VCS Research Institute. “The brigatinib Phase III clinical trial may eventually provide a potential new therapy for patients with ALK+ NSCLC, an area where more innovative therapies are desperately needed to improve response rates. Meanwhile, the Expanded Access Program will give another option to patients who have experienced failure of another TKI, offering the potential opportunity for improved outcomes to patients who are battling this complex disease.”


Patients 18 years or older with locally advanced and/or metastatic ALK+ NSCLC who are interested in participating in the clinical trial or Expanded Access Program for brigatinib can contact the VCS Research Institute at (703) 208-3192 to learn more about the criteria for participation.

The VCS Research Institute is a valuable resource for the regional medical community and is well-respected among referring physicians, patients and payers who recognize the practice’s long-standing commitment to provide the very latest treatment options to patients. Drs. Spira and Wadlow oversee a team of highly-skilled oncology research professionals who work with VCS oncologists to provide clinical trials at six convenient treatment sites throughout the area.

“We are extremely proud to conduct and enroll the very first patient in the world in the brigatinib clinical trial, as it demonstrates our leadership role in bringing exciting new therapies to cancer patients, not only in our local community, but across the global cancer community as well,” noted Karin Choquette, MSN, RN, CCRC, clinical research manager at VCS. “We are committed to leading the way in the fight against cancer while providing our patients access to the world's most advanced cancer treatments and cutting-edge clinical trials.”

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