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Find Clinical Drug Pipeline Developments & Deals for Pralsetinib
The partnership aims to assist in the commercialization of Rigel Pharmaceuticals' approved product, Gavreto (pralsetinib), which is indicated for RET fusion-positive non-small cell lung cancer.
Through the acquisition, Rigel will able to commercialize the Gavreto (pralsetinib), which is an FDA-approved targeted therapy for the treatment of RET fusion-positive metastatic non-small cell lung cancer.
Under the terms of the agreement, Blueprint Medicines will regain global commercialization and development rights to Gavreto (pralsetinib), a once-daily oral targeted therapy, excluding Greater China.
Gavreto (pralsetinib) is a kinase inhibitor of wild-type RET and oncogenic RET fusions (CCDC6-RET) and mutations. It is approved for adult patients with locally advanced or metastatic RET fusion-positive NSCLC or thyroid cancer and advanced or metastatic RET-mutant MTC.
GAVRETO is an important precision therapy that has been incredibly meaningful for patients with metastatic, RET fusion-positive non-small cell lung cancer who may have otherwise had limited options.
Preclinical data have shown that Gavreto inhibits primary RET fusions and mutations that cause cancer in subsets of patients, as well as secondary RET mutations predicted to drive resistance to treatment.
Gavreto® (pralsetinib) is approved once-daily, oral targeted treatment designed to selectively target rearranged during transfection (RET) alterations. Gavreto showed robust and durable clinical responses in people with NSCLC with RET fusions.
Pralsetinib showed robust and durable anti-tumor activity and a well-tolerated safety profile in patients that enrolled at China sites who had advanced RET fusion-positive non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.
Developed by Blueprint Medicines, GAVRETO is a new therapy indicated for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer as detected by an FDA approved test. This agreement will continue Catalent’s involvement in the GAVRETO program.
GAVRETO demonstrated consistent clinical activity in patients across lines of therapy and regardless of RET mutation genotypes, including a high response rate in patients with gatekeeper mutations resistant to multi-kinase inhibitors.
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