Benzinga | Nov 19, 2021 02:12PM EST

Roche's Gavreto Conditionally Approved In Europe For RET Fusion-Positive Lung Cancer

The European Commission (EC) has granted conditional marketing authorization to Roche Holdings AG's (OTC:RHHBY) Gavreto (pralsetinib) for treating adults with a form of non-small cell lung cancer.

* The approval covers pralsetinib as a monotherapy for treating adults with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor.

* Gavreto is the first and only precision medicine approved in the European Union for the first-line treatment of people with RET fusion-positive advanced NSCLC.

* The approval is based on the ongoing phase 1/2 ARROW study results, in which Gavreto led to durable responses in people with advanced RET fusion-positive NSCLC.

* In 75 treatment-na?ve patients, Gavreto demonstrated an overall response rate (ORR) of 72.0%, and the median duration of response (DOR) was not reached.

* In 136 patients who had previously received platinum-based chemotherapy, Gavreto demonstrated an ORR of 58.8%, and the median DOR was 22.3 months.

* Price Action: RHHBY shares are trading 0.13% lower at $49.76 during the market session on the last check Friday.