(Reuters) – Genentech said it would withdraw its use of Gabret in the United States in the treatment of a type of thyroid cancer because it was impractical for the Roche division to seek full approval of the drug, according to its partner Blueprint. Medicines announced on Friday.
The move comes after the Swiss pharmaceutical company posted more than $700 million in write-downs related to the drug last year.
In 2020, the U.S. Food and Drug Administration granted early approval to Gabreto for the treatment of patients 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy. Full approval required the drug to demonstrate clinical benefit in confirmatory trials.
After consulting with the FDA, Genentech decided not to conduct the late-stage studies needed to confirm the drug’s benefits, citing feasibility, according to Blueprint.
Genentech has previously said that the drug’s use in indications will account for a portion of its total revenue from Gabret in the US, according to Blueprint.
Blueprint does not expect Genentech’s decision to impact its $40 million to $50 million collaboration revenue forecast for this year.
Gabreto was co-developed and commercialized by US-based Genentech and Blueprint Medicines through a 2020 agreement. However, Roche decided to terminate its contract with Blueprint earlier this year. The termination will take effect in February 2024.
Gabreto has also received early approval for other indications, including the treatment of one type of lung cancer and another type of thyroid cancer.
The confirmatory studies needed to convert the drug’s early approval for other indications to full approval are underway, according to Blueprint’s regulatory filings.
(Reporting by Raghav Mahobe in Bangalore; Editing by Dhanya Ann Thoppil and Shailesh Kuber)
