Rigel Pharmaceuticals acquires U.S. rights to Gavreto (pralsetinib) from Blueprint Medicines Corporation

Rigel Pharmaceuticals, Inc. announced that it has entered into a definitive agreement to acquire the U.S. rights to Gavreto (pralsetinib) from Blueprint Medicines Corporation.

Gavreto is a once daily, small molecule, oral, kinase inhibitor of wild-type RET (rearranged during transfection) and oncogenic RET fusions. Gavreto is approved by the FDA for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

“NSCLC is the most common type of lung cancer in the U.S. with RET fusions representing 1-2% of the patient population. Gavreto is a targeted treatment option with an established safety profile that has shown durable responses in RET fusion-positive NSCLC patients and represents a compelling addition to our commercial portfolio,” said Raul Rodriguez, Rigel’s president and CEO. “We are excited about this transaction, as we continue to realize our corporate strategy to grow our hematology and oncology business while leveraging our existing commercial and medical affairs infrastructure and expertise. Gavreto is the third commercial product in our portfolio, supporting top line growth and our commitment to providing differentiated therapies to patients in need.”

Gavreto is also approved for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). This indication was approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Discussions with the FDA regarding confirmatory requirements are ongoing.