FDA News

FDA grants breakthrough therapy designation to Tafinlar for non-small cell lung cancer with BRAF mutation

The FDA has issued breakthrough therapy designation for dabrafenib for treating patients with metastatic BRAFV600E mutation-positive non-small cell lung cancer who have received at least one prior platinum-containing chemotherapy, GlaxoSmithKline announced.

The FDA used interim efficacy and safety results from an ongoing phase 2 study of dabrafenib (Tafinlar) to base the designation, which is intended to expedite development and review of drugs to treat serious or life-threatening conditions, according to a press release. Twenty-five patients with non-small cell lung cancer (NSCLC) and the BRAF V600E mutation who had received at least one previous course of chemotherapy received dabrafenib orally. The interim results were presented at the 2013 American Society for Clinical Oncology annual meeting in Chicago.

The FDA recently approvedtrametinib (Mekinist, GlaxoSmithKline) combined with dabrafenib for treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. Dabrafenib also is approved by the FDA as monotherapy for patients with metastatic or unresectable melanoma whose tumors express the BRAF V600E gene mutation.

Dabrafenib currently is not approved or licensed for treating NSCLC, and an estimated 2% of patients with NSCLC have the BRAF V600E mutation targeted by the drug, the release said.

The FDA has issued breakthrough therapy designation for dabrafenib for treating patients with metastatic BRAFV600E mutation-positive non-small cell lung cancer who have received at least one prior platinum-containing chemotherapy, GlaxoSmithKline announced.

The FDA used interim efficacy and safety results from an ongoing phase 2 study of dabrafenib (Tafinlar) to base the designation, which is intended to expedite development and review of drugs to treat serious or life-threatening conditions, according to a press release. Twenty-five patients with non-small cell lung cancer (NSCLC) and the BRAF V600E mutation who had received at least one previous course of chemotherapy received dabrafenib orally. The interim results were presented at the 2013 American Society for Clinical Oncology annual meeting in Chicago.

The FDA recently approvedtrametinib (Mekinist, GlaxoSmithKline) combined with dabrafenib for treatment of patients with unresectable melanoma or metastatic melanoma with BRAF V600E or V600K mutations. Dabrafenib also is approved by the FDA as monotherapy for patients with metastatic or unresectable melanoma whose tumors express the BRAF V600E gene mutation.

Dabrafenib currently is not approved or licensed for treating NSCLC, and an estimated 2% of patients with NSCLC have the BRAF V600E mutation targeted by the drug, the release said.