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Association details:
Evidence:
Evidence Level:
Sensitive: A1 - Approval
Title:

Manufacturing and Marketing Approval Received in Japan for ALUNBRIG® in the Treatment of ALK Fusion Gene-positive Unresectable Advanced or Recurrent Non-Small Cell Lung Cancer

Published date:
01/22/2021
Excerpt:
...Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that it has obtained approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market “ALUNBRIG® Tablets 30 mg, 90 mg" (brigatinib, development code: AP26113) as a first and second-line therapy for the treatment of patients with unresectable, advanced or recurrent ALK fusion gene-positive non-small cell lung cancer (ALK+ NSCLC).
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Study of Safety and Efficacy of Brigatinib Plus Chemotherapy or Brigatinib Only in Advanced ALK-Positive Lung Cancer (MASTERPROTOCOL ALK)

Excerpt:
...Progression Free Survival at 12 months, independent review`Overall Response Rate`Incidence, nature, and severity of adverse events`Impact of ALK fusion detection in ctDNA on 12-months progression free survival`Impact of ALK fusion detection in ctDNA on overall response rate`Intracranial overall response rate`Intracranial progression free survival at 12 months`Change from baseline of EuroQol Quality of Life 5-Dimension 5-Level Scale (EQ-5D-5L)`Time until definitive health related quality of life score deterioration...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

Survey of Brigatinib Used To Treat People With Non-Small Cell Lung Cancer

Excerpt:
...Participants with unresectable advanced/recurrent ALK fusion gene-positive non-small cell lung cancer....
Trial ID: