Cambridge, Mass. and Osaka, Japan, July 25, 2018 – Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the global, randomized, Phase 3 ALTA-1L (ALK in Lung Cancer Trial of AP26113 in 1st Line) trial met its primary endpoint at the first pre-specified interim analysis, with ALUNBRIG® (brigatinib) demonstrating a statistically significant improvement in progression-free survival (PFS) compared to crizotinib in adults with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor. The trial was designed to assess the efficacy and safety of ALUNBRIG in comparison to crizotinib based on evaluation of the primary endpoint of PFS, or length of time from the start of treatment that a patient lives without the disease getting worse. ALUNBRIG is currently not approved as frontline therapy.
Takeda’s Alunbrig (brigatinib) has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) for patients with ALK-positive advanced non-small cell lung cancer (NSCLC).
NICE has published its final appraisal of Takeda’s Alunbrig (brigatinib), recommending the therapy for the treatment of ALK-positive advanced non-small cell lung cancer (NSCLC) in patients who have not already been treated with an ALK inhibitor.
LONDON, UK, 10th December 2020 – Takeda UK Ltd. is pleased to announce that the National Institute for Health and Care Excellence (NICE) has recommended ALUNBRIG (brigatinib) as a treatment option for patients with ALK-positive advanced non-small cell lung cancer (NSCLC) that has not been previously treated with an ALK inhibitor, within a final appraisal document (FAD) published today.1 This positive recommendation has resulted from close collaborative working between Takeda, NICE, NHS England, the clinical and patient community, and means that eligible patients in England, Wales and Northern Ireland will now have access to brigatinib.
CAMBRIDGE (Massachusetts) and OSAKA (Japan) - ( BUSINESS WIRE ) - Takeda Pharmaceutical Company Limited ( TSE: 4502 / NYSE: TAK ) (“Takeda”) just announced that the company is presenting data from its cancer portfolio lung at the virtual conference of the European Oncology Society (ESMO). It should be noted that the results of the subanalyses of the ALTA 1L phase 3 study both reinforce the strong evidence of the intracranial efficacy of ALUNBRIG ®(brigatinib) as first-line treatment in patients with non-small cell lung cancer (NSCLS) positive for anaplastic lymphoma kinase (ALK +), as associated quality of life (QoL) data. Takeda is also presenting updated results from the 10-month follow-up of the phase 1/2 trial of mobocertinib (TAK-788), demonstrating that mobocertinib achieved a duration of response (DoR) of more than one year in the study population. of the study of patients with metastatic non-small cell lung cancer (mNSCLC) carrying insertion mutation in exon 20 of the epidermal growth factor receptor (EGFR).
US regulators have expanded the scope of Takeda's Alunbrig (brigatinib) to include first-line treatment of adults with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands ALUNBRIG’s current indication to include the first-line setting. ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations.
CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) approved ALUNBRIG (brigatinib) for adult patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. This approval expands ALUNBRIG’s current indication to include the first-line setting. ALUNBRIG is a potent and selective next-generation tyrosine kinase inhibitor (TKI) designed to target ALK molecular alterations.
European regulators have expanded the scope of Alunbrig (brigatinib) to include its use as a monotherapy for the treatment of adults with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) in the first-line setting.
Takeda Pharmaceutical Company Limited announced that the European Commission (EC) extended the current marketing authorization of Alunbrig (brigatinib) to include use as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously not treated with an ALK inhibitor. This decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on February 27, 2020.