Genentech withdraws use of Gavreto in US for a type of thyroid cancer, says partner Blueprint (updated)

Blueprint Medicines

30/06/2023 13:56

(Adds details on revenue impact in paragraph 6, adds background
throughout on accelerated approval)
       June 30 (Reuters) - Genentech will withdraw Gavreto from
use in the United States for treating a type of thyroid cancer
as it was not feasible for the Roche  ROG.S  unit to pursue the
drug for full approval, its partner Blueprint Medicines  BPMC.O 
said on Friday.
    The move comes after the Swiss drugmaker took an over $700
million impairment related to the drug last year.
    The U.S. Food and Drug Administration had granted
accelerated approval to Gavreto in 2020 for treating patients
aged 12 years and above with advanced or metastatic RET-mutant
medullary thyroid cancer who require systemic therapy. A full
approval would have required the drug to show clinical benefit
in confirmatory trials.
    Blueprint said Genentech decided not to pursue the
late-stage study required to confirm the drug's benefits due to
feasibility after consultation with the FDA. 
    Genentech previously said the use of the drug in the
indication accounts for a fraction of its overall revenue from
Gavreto in the United States, according to Blueprint. 
    Blueprint expects the Genentech decision to have no impact
to its collaboration revenue forecast of $40 million to $50
million this year.
    Gavreto was jointly developed and commercialized by
Genentech and Blueprint Medicines in the U.S. through a deal in
2020. Roche, however, decided to terminate the deal with
Blueprint earlier this year. The termination is effective
February 2024.
    Gavreto has also been granted accelerated approval in other
indications like treating a type of lung cancer and another type
of thyroid cancer. 
        The confirmatory studies required to convert accelerated
approval for the drug in other indications to full approval are
ongoing, according to the regulatory filing by Blueprint. 

 (Reporting by Raghav Mahobe in Bengaluru; Editing by Dhanya Ann
Thoppil and Shailesh Kuber)
 ((Raghav.Mahobe@thomsonreuters.com;))