(Reuters) -The U.S. Food and Drug Administration has approved Merus NV’s therapy that targets a particular gene, offering a treatment option for patients with hard-to-treat type of lung and pancreatic cancers, the health regulator said on Wednesday.
The therapy, branded as Bizengri, targets the NRG1 gene, which is associated with formation and progression of several tumors.
Bizengri, Merus’ first commercial product, is expected to be available to patients in the coming weeks, the company said.
Merus did not immediately respond to a Reuters request for comment on pricing.
It is the first approved therapy for patients with the type of non-small cell lung cancer and pancreatic adenocarcinoma harboring an NRG1 gene fusion.
The therapy works by blocking the interaction between a protein called HER3 and the NRG1 gene, which in turns inhibits the growth of tumor cells.
Non-small lung cancer is the most common type of lung cancer, while pancreatic adenocarcinoma accounts for more than 90% of pancreatic cancer cases.
Bizengri was approved for the types of cancer patients whose disease worsened on or after prior systemic therapy, the FDA said.
The recommended dose of the therapy is 750 milligrams, as an intravenous infusion every 2 weeks, the health regulator said.
BMO Capital Markets analyst Etzer Darout expects global peak sales to be about $462 million for Bizengri.
The therapy was studied in a early-to-mid stage trial which enrolled 64 adults with the type of lung cancer and 30 adults with pancreatic adenocarcinoma whose disease worsened following standard of care treatment.
The therapy showed it can help reduce or destroy the disease in 40% of pancreatic cancer patients and 33% of lung cancer patients.
On Monday, the company announced an agreement with Partner Therapeutics, under which the private biotech would assume full rights to U.S. commercialization of Bizengri.
(Reporting by Sriparna Roy, Bhanvi Satija and Christy Santhosh in Bengaluru; Editing by Krishna Chandra Eluri)
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