After Roche’s exit, Blueprint passes Gavreto on to Rigel

handing over commercial rights

Almost a year to the day after Roche pulled out a partnership on its underperforming cancer therapy Gavreto, Blueprint Medicines has sold US commercial rights to the drug to Rigel Pharma in a deal worth up to $117.5 million.

The product, an oral RET inhibitor, was approved in 2020 by the FDA to treat adults with metastatic RET fusion-positive non-small-cell lung cancer (NSCLC), shortly after Roche paid $775 million upfront to license the drug.

Gavreto (pralsetinib) has since picked up an additional accelerated approval in RET-positive thyroid cancer, although, that was withdrawn after a confirmatory trial failed to show a benefit. The product has failed to gather much sales momentum, with US revenues coming in at $28 million last year, according to Rigel.

Roche started the termination process last year, saying it would take a year to exit the alliance, and Rigel has stepped in as that came to a close.

Gavreto has been in direct competition with Eli Lilly’s first-to-market RET inhibitor Retevmo (selpercatinib), which has also started slowly since its FDA approval for RET-positive NSCLC and thyroid cancer in 2020. Lilly recorded worldwide sales of $117 million for Retevmo last year, buoyed by a 2022 approval for all RET-positive tumours, regardless of their location in the body.

Take-up of both products has been pegged back by challenges in diagnosis and biomarker testing for RET inhibitors, including skills gaps and “systems-level barriers” that impede access to testing, according to a recent paper in the journal BMC Medical Education. RET mutations are seen in 1% to 2% of patients with NSCLC, the leading cause of cancer death in the US, with around 190,000 cases diagnosed every year.

Rigel's chief executive, Dave Santos, has said the company is confident in the potential of Gavreto, given there are only two RET products on the market, and that it will “transition Gavreto to [its] distribution network and utilise [its] robust capabilities to enable both existing and new patients to continue to have access to this important treatment option.”

The company is paying $15 million for Gavreto, including $10 million on its first commercial sale and $5 million on the first anniversary of the deal. Blueprint is also eligible to receive up to $97.5 million and $5 million in commercial and regulatory milestone payments, respectively.

Blueprint confirmed in a filing with the Securities & Exchange Commission (SEC) that it is stopping the development and marketing of the drug in ex-US markets, except for Greater China (mainland China, Hong Kong, Macau, and Taiwan), where it has a partnership with CStone Pharmaceuticals.

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