On September 4, 2020, Genentech, a Roche company, announced that the U.S. Food and Drug Administration (FDA) has approved pramintinib (Gavreto) for the treatment of adult patients with metastatic transfection rearrangement (RET) fusion-positive non-small cell lung cancer (NSCLC) confirmed by an FDA-approved assay.
This indication was approved through the FDA's accelerated approval process based on data from the Phase I/II ARROW study. Continued approval for this indication may depend on validation and description of clinical benefit in confirmatory trials.
Pramintinib (Gavreto) is a once-daily oral precision therapy designed to selectively target RET gene alterations, including fusions and mutations.
“FDA approval of Gavreto for the treatment of RET fusion-positive non-small cell lung cancer is a significant step towards our goal of providing effective treatment options for every patient diagnosed with lung cancer, regardless of how rare or difficult-to-treat their cancer type may be,” said Levi Garave, MD, PhD, Chief Medical Officer and Head of Global Product Development. “We are committed to finding personalized treatment options for cancer patients based on specific genomic or molecular alterations, and we look forward to collaborating with Blueprint Medicines to further explore the potential of pralatinib (Gavreto) in various tumor types with RET gene alterations.”
About RET
RET activation fusions and mutations are key disease drivers in many cancer types, including non-small cell lung cancer and medullary thyroid carcinoma (MTC), but treatment options that selectively target these gene alterations are limited. In non-small cell lung cancer, RET fusions account for approximately 1%–2% of patients. Biomarker detection of these fusions is the most effective method for identifying patients suitable for pralatinib (Gavreto) treatment.
About Pravlatinib (Gavreto)
Pravlatinib (Gavreto) is a once-daily oral precision therapy designed to selectively target RET gene alterations, including fusions and mutations, regardless of their tissue of origin. Preclinical data indicate that Pravlatinib (Gavreto) inhibits primary RET fusions and mutations that cause cancer in some patients, as well as secondary RET mutations that are expected to lead to treatment resistance. Blueprint Medicines and Genentech are also jointly developing Pravlatinib (Gavreto) for the treatment of patients with thyroid cancer and other solid tumors with various RET gene alterations.
