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 ("Blueprint"). 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 U.S. Food and Drug Administration (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.

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. Under the terms of the agreement, Blueprint will receive a purchase price of $15.0 million, $10.0 million of which is payable upon first commercial sale by Rigel and an additional $5.0 million of which is payable on the first anniversary of the closing date, subject to certain conditions. Blueprint is also eligible to receive up to $97.5 million in future commercial milestone payments and up to $5.0 million in future regulatory milestone payments, in addition to tiered royalties ranging from 10% to 30%.

Patents that have issued or are expected to issue covering GAVRETO will have statutory expiration dates between 2036 and 2041. Rigel expects to complete the transition of the asset and start recognizing product sales in the third quarter of 2024. Rigel will provide additional details on this transaction at its upcoming quarterly earnings call in early March.  Rigel's acquisition of the U.S. rights to GAVRETO is concurrent to a previously announced Roche decision to terminate the GAVRETO collaboration agreement with Blueprint effective February 22, 2024.

According to a statement from the company, Genentech, a member of the Roche Group, is committed to patients and working with Rigel and Blueprint to ensure current and newly prescribed patients can access GAVRETO without interruption through the transition period, with specific next steps and timing to be communicated to key stakeholders, including healthcare providers, in the next few weeks.