Japan-based pharmaceutical company Takeda has secured the US Food and Drug Administration (FDA) approval for ALUNBRIG (brigatinib) to treat a rare type of non-small cell lung cancer (NSCLC).

The US regulatory agency has indicated ALUNBRIG to treat patients with anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC, detected by an FDA-approved test.

ALUNBRIG is a selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations. The FDA approval expands the ALUNBRIG’s indication to include the first-line setting, said the company.

Takeda global oncology business unit president Teresa Bitetti 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.”

The FDA approval for ALUNBRIG is based on Phase 3 ALTA 1L trial results

The pharmaceutical firm said that the FDA approval is based on results from the Phase 3 ALK in Lung Cancer Trial of BrigAtinib in 1st Line (ALTA 1L) trial, which evaluated the safety and efficacy of ALUNBRIG compared to crizotinib.

Phase 3 ALTA 1L trial is an ongoing, randomised, open-label, comparative, multicentre trial, which enrolled 275 adult patients with ALK+ locally advanced or metastatic NSCLC, who did not receive prior treatment with an ALK inhibitor.

In the clinical study, ALUNBRIG has reduced the risk of disease progression or death compared to crizotinib, with a 24-month median progression-free survival (PFS) as assessed by a blinded independent review committee (BIRC) compared to 11 months for crizotinib.

In addition, ALUNBRIG showed 74% confirmed overall response rate (ORR), where crizotinib showed 62%, as assessed by a BIRC. ALUNBRIG demonstrated a confirmed intracranial ORR for patients with measurable brain metastases at baseline of 78%, where crizotinib showed 26%.

The most common adverse reactions in the ALTA 1L trial include diarrhoea, rash, cough, hypertension, fatigue, nausea, myalgia, dyspnea, abdominal pain, and headache.