Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq®(atezolizumab) in combination with Abraxane® (albumin-bound paclitaxel; nab-paclitaxel) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumor aberrations. The FDA is expected to make a decision on approval by September 2, 2019.
“We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease.”
This sBLA is based on results from the Phase III IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with metastatic non-squamous NSCLC.
The FDA recently approved Tecentriq in combination with Avastin®, paclitaxel and carboplatin (chemotherapy) for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations. Tecentriq is also approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA approved therapy for NSCLC harboring these aberrations prior to receiving Tecentriq.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.