Roche, Blueprint lung cancer drug wins FDA approval

Roche Holding AG on Friday said a therapy it co-developed with Cambridge-based Blueprint Medicines Corp was approved by the U.S. health regulator for the treatment of patients with a type of non-small cell lung cancer (NSCLC).

The drug, Gavreto, is an oral therapy which selectively targets so-called RET-altered cancers that have mutations that drive tumor growth, which are detected by a test approved by the U.S. Food and Drug Administration.

Swiss drugmaker Roche in July struck a pact worth up to $1.7 billion with Blueprint Medicines, for rights to Gavreto, which also awaits FDA approval for treating advanced RET mutant and RET fusion-positive thyroid cancers.

The drug will be jointly marketed in the United States and will be available within a week, Blueprint said.

Only about 1-2% of patients with NSCLC have RET fusions, according to Roche.

https://www.reuters.com/article/us-roche-hldg-fda-blueprint/roche-blueprint-lung-cancer-drug-wins-fda-approval-idUSKBN25W00D