Additionally, stable disease was observed in 9 patients and no patients had progressive disease. The best response was a partial response, which was achieved in 91% of patients. The disease control rate seen in patients with RET fusion-positive thyroid cancers was 100% (95% CI, 72%-100%). In a cohort of 13 patients with RET fusion-positive MTC in the phase 1/2 ARROW study of pralsetinib in patients with select RET fusion-positive solid tumors, the MTC cohort achieved an objective response rate (ORR) of 74% in the treatment-naïve patients and an ORR of 60% in patients who had previous treatment. In May, the FDA approved another oral RET therapy, Eli Lilly’s selpercatinib (Retevmo), also for NSCLC and MTC. “Beyond lung cancer, pralsetinib’s tumour-agnostic potential further expands Roche's ongoing commitment to finding new approaches to treat cancer in a more personalised way based on the genetic mutation of the disease, irrespective of the tumour site of origin,” Roche said in a statement. The once-daily oral precision therapy has also shown promise as a tumor-agnostic treatment. It has also submitted a marketing authorization application to the European Medicines Agency. In May, it submitted an NDA for pralsetinib in locally advanced or metastatic RET fusion-positive non–small cell lung cancer (NSCLC), with an expected decision by November 23, 2020. Pralsetinib is an investigational inhibitor of RET fusions and mutations.Įarlier this month, Blueprint Medicines submitted a new drug application (NDA) for pralsetinib to the FDA under priority review for treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers. The 2 companies will jointly market pralsetinib in the United States, if it is approved, while Roche will be responsible for commercial activities outside the United States, excluding Greater China. Roche will pay $675 million in cash in addition to a $100 million equity investment Blueprint Medicines is eligible to receive up to $927 million in potential milestones, plus royalties on net product sales outside the United States. Roche said Tuesday it will invest heavily in Blueprint Medicines on a global codevelopment and commercialization agreement for pralsetinib, an investigational precision therapy in late-stage development for individuals with alterations in the RET gene.
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