Platinib treats RET gene fusion lung cancer

On September 4, 2020, the U.S. Food and Drug Administration granted accelerated approval to pralsetinib (GAVRETO) for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by a U.S. FDA-approved test.

On September 4, 2020, the U.S. FDA also approved the Oncomine Dx Target (ODxT) test (Life Technologies Corporation) as a companion diagnostic to pralsetinib.

Efficacy was investigated in patients whose tumors had RET alterations in a multicenter, open-label, multi-cohort clinical trial (ARROW, NCT03037385). Identification of RET gene alterations was prospectively determined by local laboratories using next-generation sequencing, fluorescence in situ hybridization, or other testing. The primary efficacy outcome measures were overall response rate (ORR) and duration of response as determined by a blinded independent review committee using RECIST 1.1.

Efficacy in RET fusion-positive NSCLC was evaluated in 87 patients who had received prior platinum-based chemotherapy. The ORR was 57% (95% CI: 46%, 68%); 80% of responding patients had responses lasting 6 months or longer. Efficacy was also evaluated in 27 patients who had never received systemic therapy. The ORR in these patients was 70% (95% CI: 50%, 86%); 58% of patients who responded had responses lasting 6 months or longer.

The most common adverse reactions, including laboratory abnormalities (≥25%), are increased aspartate aminotransferase (AST), decreased hemoglobin, lymphopenia, neutropenia, increased alanine aminotransferase (ALT), increased creatinine, increased alkaline phosphatase, fatigue, constipation, musculoskeletal pain, decreased calcium, hypertension, decreased sodium, decreased phosphate, and thrombocytopenia.

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

Currently, patients can purchase platinib directly in China without seeking overseas channels. The drug is produced by Catalent CTS in the United States. The specification is 100mg*120 tablets. The market price is about 20,000 yuan per box. Unfortunately, Platinib has not yet been included in my country’s medical insurance reimbursement scope. At the same time, the original drug Platinib sold overseas is priced at 159,000 yuan (US version) and 45,000 yuan (European version) per box of 60 pills. In addition, Lucius, Laos has launched a generic version of platinib, which is affordable and only costs about 4,600 yuan.