Pralsetinib (Gavreto) is an oral kinase inhibitor primarily indicated for the treatment of specific malignant tumors associated with RET gene alterations. Manufactured by Genentech, this drug first received approval for marketing in the United States in 2020.
What Are the Indications for Pralsetinib (Gavreto)?
Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer (NSCLC)
This drug is indicated for adult patients with metastatic RET fusion-positive non-small cell lung cancer confirmed by an FDA-approved testing method.
Clinical studies have demonstrated that pralsetinib exhibits significant antitumor activity in patients previously treated with platinum-based chemotherapy, with a high overall response rate and a prolonged duration of response.
RET Fusion-Positive Thyroid Cancer
Pralsetinib is also indicated for patients aged 12 years and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are refractory to radioactive iodine therapy (if applicable).
This indication was granted accelerated approval based on the overall response rate and duration of response, and its continued approval may be contingent upon the results of subsequent confirmatory clinical trials.
Dosage Form, Specifications and Characteristics of Pralsetinib (Gavreto)
Dosage Form and Strength
Pralsetinib is available as hard capsules, with each capsule containing 100 mg of the active ingredient pralsetinib.
Packaging Specifications
The drug is packaged in high-density polyethylene (HDPE) bottles, offered in three packaging sizes: 60 capsules, 90 capsules, or 120 capsules per bottle.
Each packaging bottle is labeled with a National Drug Code (NDC) to facilitate circulation and management.
Appearance and Characteristics
The capsules are light blue and opaque, with shells made of hypromellose (HPMC).
The body of the capsule is printed with the marking "BLU-667", and the cap is printed with "100mg" for easy identification and verification.
Excipient Ingredients
In addition to the active ingredient, each capsule contains the following inactive excipients: citric acid, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium bicarbonate.
The capsule shell contains FD&C Blue No. 1, hypromellose, and titanium dioxide.
The printing ink contains butyl alcohol, anhydrous ethanol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, strong ammonia solution, and titanium dioxide.
Storage Methods for Pralsetinib (Gavreto)
Storage Conditions
Pralsetinib capsules should be stored at room temperature between 20°C and 25°C (68°F and 77°F).
Short-term exposure to temperatures ranging from 15°C to 30°C (59°F to 86°F) is permissible.
The drug must be stored in a sealed container and protected strictly from moisture to prevent capsule degradation due to dampness.
