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2023-02-24|

Roche Returns Gavreto Rights To Blueprint After Ditching Collaboration

by Joy Lin
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Blueprint Medicines Corporation has announced that it will regain global development and marketing rights to Gavreto (pralsetinib) after Roche terminated the partnership for the cancer drug for “strategic reasons”. 

Roche’s Genentech licensed Gavreto from Blueprint in July 2020, paying the company $775 million upfront payment while promising up to $927 million in milestones in exchange for ex-US rights to Gavereto, excluding the Greater China region. 

Blueprint has since reaped roughly $1 billion between upfront and milestone payments and from cost-sharing the development and commercialization of Gavreto. 

According to Blueprint, Roche’s pullout is not expected to impact 2023 revenue guidance, which includes $40-50 million in revenues from existing collaborations and annual operating expenses.   

The termination will take effect 12 months from February 22, 2023. The companies have affirmed their commitment to ensure a smooth transition process with no interruptions or changes to patient care. The company will explore options to advance and simplify the continued global commercialization and development of Gavreto, said Blueprint. 

“Over the next year, we will work alongside Roche to transition the Gavreto program. In parallel, Blueprint will determine the optimal path forward to bring Gavreto to patients in a way that maximizes its impact and value,” said Kate Haviland, CEO of Blueprint.

“As we do this, we will remain focused on our 2023 goals, with our highest priorities being the anticipated US launch of Ayvakit (avapritinib) in indolent systemic mastocytosis and the ongoing advancement of our pipeline of investigational medicines.”

Related Article: Will Breakthrough Therapy Lead the Way? An Overview of the Approved Gene and Cell Therapies for 2022

Gavreto Approved to Treat Cancers with RET Mutations

Gavreto, a once-daily oral targeted therapy, is designed to target oncogenes RET alterations, including secondary RET mutations that may confer resistance to treatment.

The drug has been approved by the US FDA to treat metastatic RET fusion-positive non-small cell lung cancer (NSCLC), advanced or metastatic RETmutant medullary thyroid cancer (MTC), and advanced or metastatic RET fusion-positive thyroid cancer. 

The European Commission has conditionally approved the drug to treat adult patients with RET fusion-positive advanced NSCLC not previously treated with a RET inhibitor. 

In China, the drug has been approved by the National Medical Products Administration for similar indications as the three approved by the US FDA. 

Since 2018, Blueprint has an ongoing licensing partnership with CStone Pharmaceuticals for the development and marketing of Gavreto in the Greater China region, which includes Mainland China, Hong Kong, Macau, and Taiwan. 

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