Lefamulin Tablets and Trametinib Dimethyl Sulfoxide

• Generic Name: lefamulin
• Dosage Forms: n.a.
• Other Brand Names: Xenleta

• It is used to treat a type of bacterial infection.

• Generic Name: trametinib
• Dosage Forms: n.a.
• Other Brand Names: Mekinist

In combination with dabrafenib as adjuvant therapy following complete resection of melanoma with BRAF V600E or V600K mutation and nodal involvement.

Alone or in combination with dabrafenib for treatment of unresectable or metastatic melanoma in selected patients with BRAF V600E or V600K mutation (designated an orphan drug by FDA as monotherapy or when used in combination for this use).

FDA-approved in vitro diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E or V600K mutation prior to initiation of monotherapy or combination therapy.

Not recommended for use in patients with melanoma who have experienced disease progression following treatment with a BRAF inhibitor.

Used in combination with dabrafenib for treatment of metastatic non-small cell lung cancer (NSCLC) in patients with BRAF V600E mutation (designated an orphan drug by FDA when used in combination for this use).

FDA-approved diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E mutation prior to initiation of therapy.

Used in combination with dabrafenib for treatment of locally advanced or metastatic anaplastic thyroid cancer in patients with BRAF V600E mutation when no satisfactory locoregional treatment options are available (designated an orphan drug by FDA when used in combination for this use).

FDA-approved diagnostic test (e.g., THxID BRAF kit) required to confirm presence of BRAF V600E mutation prior to initiation of therapy.