Defactinib Hydrochloride (1 brand name, 1 dosage form, 1 route)
Available dosage forms: CAPSULE, TABLET.
Routes of administration: ORAL.
Brand Names
- AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)
Indications and Usage
AVMAPKI FAKZYNJA CO-PACK is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Contraindications
None.
Adverse Reactions
The following adverse reactions are discussed in more detail in other sections of the labeling: Ocular Toxicities [see Warnings and Precautions (5.1)] Serious Skin Toxicities [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Rhabdomyolysis [see Warnings and Precautions (5.4)]