Genentech, the US biotech subsidiary of Swiss pharma giant Roche (ROG: SIX), plans to withdraw Gavreto (pralsetinib) from use in the USA for the treatment of a type of RET+ medullary thyroid cancer (MTC) as it was not feasible to pursue the drug for full approval, its partner Blueprint Medicines (Nasdaq: BPMC) said on Friday.
While the collaboration agreement was terminated in February, Roche is still the news drug application (NDA) sponsor in the USA. The decision came more than two years after Roche paid $775 million up front to in-license the RET inhibitor, as part of a $1.7 billion deal with Blueprint, at which point the latter had already received about $1 billion. Gavreto had been approved under the US accelerated approval program, which requires a subsequent confirmatory trial to gain full approval.
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