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Roche/Genentech Set Lower Rozlytrek Price To Catch Up With Bayer’s Vitrakvi

 
• By Mandy Jackson

Entrectinib clinched double approvals in the US for ROS1-positive NSCLC and for tumors with NTRK gene fusions – making it the third tumor-agnostic and second NTRK-fusion approval in the US.

Red Approved Stamp with Wooden handle Rubber Stamper Isolated on White Background.
Rozlytrek will compete with Vitrakvi for NTRK gene fusion patients. • Source: Shutterstock

Roche's Genentech Inc. announced US Food and Drug Administration approval on 15 August for Rozlytrek (entrectinib) in two indications, making it the second drug approved in the US for solid tumors with a neurotrophic tyrosine receptor kinase (NTRK) gene fusion regardless of tumor type, behind Bayer AG's Vitrakvi (larotrectinib), which was cleared by the FDA last year.

Rozlytrek gained full approval to treat adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC) as well as accelerated approval to treat adults and children aged 12 and older with NTRK gene fusions whose tumors do not have a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in

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