Repotrectinib (Augtyro) is an innovative kinase inhibitor that received its first approval from the U.S. Food and Drug Administration (FDA) in 2023. As a next-generation targeted therapy, repotrectinib, with its unique mechanism of action and precise molecular targeting design, provides a new treatment option for cancer patients with specific gene mutations.

Indications for Repotrectinib (Augtyro)

Therapeutic Areas

ROS1-positive non-small cell lung cancer (NSCLC): Treatment of locally advanced or metastatic ROS1-positive NSCLC in adult patients.

NTRK gene fusion-positive solid tumors: Treatment of locally advanced or metastatic solid tumors in adult patients and pediatric patients aged 12 years and older, with specific genetic conditions and treatment history requirements to be met.

Specific Indication Characteristics

ROS1-positive NSCLC: Adult patients with confirmed ROS1 rearrangement via testing.

NTRK gene fusion-positive solid tumors: Presence of NTRK gene fusion confirmed by molecular testing.

Accelerated Approval Conditions

The indication for NTRK gene fusion-positive solid tumors was approved under the accelerated approval pathway. Its continued approval may be contingent on the verification and description of clinical benefit in confirmatory trials.

Dosage Forms and Characteristics of Repotrectinib (Augtyro)

Capsule Specifications

40 mg capsules: Opaque white, immediate-release, size 0 hard-shell capsules filled with white to off-white powder (may appear as lumps). The capsule cap is imprinted with "REP40" in blue ink.

160 mg capsules: Opaque blue, immediate-release, size 0 hard-shell capsules filled with white to off-white powder (may appear as lumps). The capsule cap is imprinted with "REP160" in white ink.

Packaging Specifications

40 mg strength: Available in two packaging options: 60 capsules per bottle and 120 capsules per bottle.

160 mg strength: Available in two packaging options: 14 capsules per bottle and 60 capsules per bottle.

Drug Composition

Active ingredient: Repotrectinib.

Inactive ingredients: Microcrystalline cellulose, sodium lauryl sulfate, croscarmellose sodium, and colloidal silicon dioxide.

Storage Instructions for Repotrectinib (Augtyro)

Standard Storage Conditions

Temperature requirement: Store at 20°C to 25°C (68°F to 77°F), with allowable short-term excursions between 15°C and 30°C (59°F and 86°F).

Usage Precautions

Capsule integrity: Do not take any repotrectinib capsules that are broken, cracked, or damaged.

Environmental control: Store in a secure location out of the reach of children. Protect from direct sunlight, humid environments, and exposure to heat sources.