Pfizer’s Lorbrena (lorlatinib) Receives FDA Approval for Patients with 1L ALK- Positive Metastatic NSCLC

 Pfizer’s Lorbrena (lorlatinib) Receives FDA Approval for Patients with 1L ALK- Positive Metastatic NSCLC

Pfizer and Zenith Epigenetics Collaborates to Evaluate ZEN-3694 & Talazoparib for TNBC

Shots:

  • The approval is based on P-I/II (B7461001) study assessing Lorbrena (100mg, qd) in 215 patients with ALK-positive metastatic NSCLC, who were treated with one or more ALK TKIs
  • The P-I/II (B7461001) study resulted in ORR (48%) with intracranial response rate 60% with serious AEs 32% out of 295 patients
  • Lorbrena (lorlatinib) is a third-generation anaplastic lymphoma kinase (ALK) TKI indicated for patients with anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC and is currently approved in Japan for ALK fusion gene-positive unresectable advanced and/or recurrent NSCLC with resistance or intolerance to ALK TKI

Click here to read full press release/ article | Ref: Pfizer | Image: Pharma News