Date: 27-May-2020

FDA Approves Takedas ALUNBRIG ® (brigatinib) As A First-line Treatment For Patients With Rare And Severe Forms Of Lung Cancer

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) is approved for ALUNBRIG (Brigatinib) for adult patients with anaplastic lymphoma kinase (ALK) positive, metastatic, non-small cell lung cancer (NSCLC), which was diagnosed by an FDA-approved test. This approval extends ALUNBRIG's current indication to first-line treatment. ALUNBRIG is a highly effective and selective tyrosine kinase inhibitor (TKI) that targets ALK molecule changes.

"We are very pleased with the positive results that ALUNBRIG has shown in patients with a new diagnosis of ALK-positive NSCLC, especially in patients with brain metastases," said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. “With a robust clinical development program and ongoing trials across the NSCLC treatment environment, Takeda is committed to researching solutions for people with devastating forms of lung cancer who need new options. In our opinion, approval of ALUNBRIG is a significant step in the right direction and a significant step forward for Takeda's overall lung cancer portfolio. ”

The approval is based on results from the ALTA 1L phase 3 study to evaluate the safety and efficacy of ALUNBRIG compared to crizotinib in adult patients with ALK-positive, locally advanced or metastatic NSCLC who have not previously received therapy with an ALK inhibitor to have.

“Following the results of the ALTA 1L study, brigatinib is now being added to the very short list of crizotinib that has been proven to be superior to first-line therapies for patients with ALK-positive lung cancer. Brigatinib showed superior efficacy compared to crizotinib, especially in patients with brain metastases at baseline and, with one tablet a day, fewer tablets. This is an important aspect because the disease may need to be kept under control for years, "said Dr. Ross Camidge, MD, PhD, Joyce Zeff Chair, Lung Cancer Research, University of Colorado Cancer Center. "These data demonstrate the potential of brigatinib as a first-line therapy and I am convinced that the FDA approval will open up new opportunities for the medical community and patients."

After more than two years of follow-up, the results of the ALTA 1L study showed that ALUNBRIG crizotinib is superior, because a significant tumor-fighting effect was observed, especially in patients with brain metastases at the start of the study.

  • ALUNBRIG reduced the risk of disease progression or death by two times compared to crizotinib (PFS hazard ratio = 0.49) with a median progression-free survival (PFS) of 24 months, as assessed by a blinded independent examination board (BIRC), compared to 11 months with crizotinib .
  • ALUNBRIG showed a confirmed overall response rate (ORR) of 74 percent (95% CI: 66-81) for ALUNBRIG and 62 percent (95% CI: 53-70) for crizotinib, assessed by a BIRC.
  • ALUNBRIG showed a confirmed intracranial ORR of 78 percent (95% CI: 52–94) in the patients treated with ALUNBRIG with measurable brain metastases at baseline and 26 percent (95% CI: 10-48) in patients treated with crizotinib .

"Like many other forms of lung cancer, ALK-positive NSCLC is a complex and aggressive type of cancer that presents newly diagnosed patients with a variety of challenges, including those who have the disease spread to the brain," said Andrea Stern Ferris, President and CEO , LUNGevity Foundation. "This new option for newly diagnosed patients is promising news for the ALK-positive NSCLC community and another remarkable advance in the treatment of lung cancer that has been greatly improved over the past decade