Platinib for the treatment of RET gene fusion non-small cell lung cancer

On August 9, 2023, the U.S. Food and Drug Administration granted regular approval to pralsetinib (Gavreto) for the treatment of adult patients with metastatic rearrangement during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC). Platinib belongs to a class of drugs called kinase inhibitors. It works by blocking the action of a natural substance that may be necessary to help cancer cells multiply.

Platinib previously received accelerated approval for the NSCLC indication on September 4, 2020, based on initial overall response rate (ORR) and duration of response (DOR) in 114 patients in the ARROW trial (NCT03037385), a multicenter, open-label, multi-cohort trial. Conversion to routine approval was based on data from an additional 123 patients and an additional 25 months of follow-up to assess durability of efficacy.

Efficacy was demonstrated in a total of 237 patients with locally advanced or metastatic RET fusion-positive NSCLC. Patients received platinib until disease progression or unacceptable toxicity.

The primary efficacy endpoints were ORR and DOR as determined by a Blinded Independent Review Committee (BIRC). Among 107 treatment-naïve patients, the ORR was 78% (95% CI: 68, 85) and the median DOR was 13.4 months (95% CI: 9.4, 23.1). Among 130 patients who had received prior platinum-based chemotherapy, the ORR was 63% (95% CI: 54, 71) and the median DOR was 38.8 months (95% CI: 14.8, not estimable).

The most common adverse reactions (≥25%) are musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough.

The recommended dose of platinib is 400 mg taken orally once daily. Take platinib on an empty stomach (fast at least 2 hours before and 1 hour after taking platinib).

Platinib is now available in the domestic market. Patients who need the original version do not need to purchase it overseas and can purchase it directly in China. This drug, produced by Catalent CTS in the United States, contains 120 capsules of 100 mg per box and is priced at about 20,000 yuan. However, it should be noted that Platinib has not yet been included in my country’s medical insurance system. At the same time, the overseas version of Platinib, with a specification of 100 mg and 60 tablets, has a price of up to 159,000 yuan per box in the United States, while in Europe it is about 45,000 yuan. It is worth mentioning that Lucius, Laos has launched a generic version of platinib, and the price of the drug with the same specifications is only about 4,600 yuan.