FDA greenlights Gavreto for advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer in over-12s
pharmafile | December 2, 2020 | News story | Research and Development, Sales and Marketing | FDA, Gavreto, Roche
The FDA has awarded accelerated approval to Roche and Blueprint Medicines’ Gavreto (pralsetinib) for the treatment of advanced or metastatic rearranged during transfection (RET)-mutant medullary thyroid cancer (MTC) in patients at least 12 years old.
Specifically, the decision relates to those in need of systemic therapy, or with advanced or metastatic RET fusion-positive thyroid cancer who also need systemic therapy and are radioactive iodine-refractory.
Phase 1/2 data supplied to the FDA in support of the application demonstrated that Gavreto induced “durable clinical activity” regardless of patient RET alteration genotypes and whether or not they had received prior therapy. The treatment generated an overall response rate (ORR) of 60% in 55 patients with RET-mutant metastatic disease who had previously received cabozantinib and/or vandetanib; in 29 patients who had not received either of these treatments and were not eligible for standard therapy, the ORR was 66%.
In nine patients with RET fusion-positive metastatic thyroid cancer, ORR reached 89%. Median duration of response was not reached in any of these treatment groups.
“We are proud to partner with Blueprint Medicines to bring this important new option to people with certain types of RET-altered thyroid cancer,” remarked Dr Levi Garraway, Chief Medical Officer and Head of Global Product Development at Roche. “Gavreto is now approved across multiple RET-altered tumour types, underscoring our commitment to advancing personalised healthcare with treatments that target the underlying biology of each person’s cancer.”
Matt Fellows
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