FDA approves Takeda’s first-line treatment option for non-small cell lung cancer
pharmafile | May 26, 2020 | News story | Manufacturing and Production | FDA, Takeda, approval
The FDA has approved Takeda’s Alunbrig (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) in a first-line setting.
The approval is based on results from the Phase 3 ALTA trial, which enrolled 275 patients with the condition, with them either receiving Alunbrig 180 mg orally once daily with seven-day lead-in at 90 mg once daily, or crizotinib, 250 mg orally twice daily.
The results showed the drug reduced the risk of diseases progression or death twofold compared with crizotinib, with a 24 month median progression free survival versus 11 months with crizotinib. It also demonstrated a confirmed overall response rate (ORR) of 74% for Alunbrig and 62% for crizotinib.
Teresa Bitetti, President, Global Oncology Business Unit at Takeda, said: “We’re extremely proud of the positive results ALUNBRIG has shown for newly diagnosed ALK+ NSCLC patients, particularly those with brain metastases.
“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.”
Some patients on the trial did suffer some adverse reactions, occurring in 33% of participants. The most common serious reactions other than disease progression were pneumonia, ILD/pneumonitis, pyrexia, dyspnea, pulmonary embolism, and asthenia. Some side effects were fatal with some patients succumbing to pneumonia, cerebrovascular accident and multiple organ dysfunction syndrome.
Conor Kavanagh
Related Content
MRM Health’s ulcerative colitis treatment receives FDA Investigational New Drug clearance
Microbial Resource Management (MRM) Health has announced that its lead programme, MH002, has received Investigational …
Complement Therapeutics’ geographic atrophy treatment receives FDA Fast Track designation
Complement Therapeutics has announced that CTx001, its gene therapy treatment for geographic atrophy (GA) secondary …
Johnson & Johnson submits robotic surgical system for De Novo classification
Johnson & Johnson has announced the submission of its Ottava Robotic Surgical System for De …
