Takeda drug approved for first-line treatment of patients with metastatic lung cancer

Pharma News: Takeda announced the expanded approval of ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

This U.S. Food and Drug Administration’s (FDA) approval expands ALUNBRIG’s current indication to include the first-line setting. ALUNBRIG is a selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations.

In Australia, ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. The PBAC noted in November 2019 that Takeda would submit the data for the first-line indication to the TGA in early 2020, with registration expected in March 2021.

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“We’re extremely proud of the positive results ALUNBRIG has shown for newly diagnosed ALK+ NSCLC patients, particularly those with brain metastases,” said Teresa Bitetti, President, Global Oncology Business Unit, Takeda. “Through a robust clinical development program and ongoing investigations across the NSCLC treatment landscape, Takeda is committed to uncovering solutions for people living with devastating forms of lung cancer in need of new options. We believe this approval for ALUNBRIG is a substantial step in the right direction and represents significant progress for Takeda’s broader lung cancer portfolio.”

The approval is based on results from the Phase III ALTA 1L trial, which is evaluating the safety and efficacy of ALUNBRIG compared to crizotinib in adult patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor.

Results from the ALTA 1L trial add brigatinib to the very short list of first-line treatment options for ALK+ lung cancer patients that have proven to be superior to crizotinib. Compared to crizotinib, brigatinib demonstrated superior efficacy, especially among those with brain metastases at baseline, and a low pill burden, at one pill a day, which is an important factor when we could be controlling disease for years,” said Ross Camidge, MD, PhD, Joyce Zeff Chair in Lung Cancer Research, University of Colorado Cancer Center. “These data have established brigatinib’s potential in the first-line setting.”

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After more than two years of follow-up, results from the ALTA 1L trial showed ALUNBRIG demonstrated superiority over crizotinib, with significant anti-tumor activity observed, especially in patients with baseline brain metastases.

“As with many forms of lung cancer, ALK+ NSCLC is a complex and aggressive cancer that presents various treatment challenges for patients who are newly diagnosed, including those whose disease has spread to their brain,” said Andrea Stern Ferris, President and CEO, LUNGevity Foundation. “Having this option for newly diagnosed patients is exciting news for the ALK+ NSCLC community and adds to the remarkable progress we have witnessed in lung cancer treatment over the past decade.”