Merus’ week keeps getting better. Days after securing a long-awaited commercialization partner for its zenocutuzumab, the drug has crossed the FDA finish line as the first therapy to target cancers that harbor a neuregulin 1 (NRG1) gene fusion.
The FDA granted an accelerated approval for the drug, branded as Bizengri, to treat NRG1 fusion-positive non-small cell lung cancer (NSCLC) and NRG1 fusion-positive pancreatic adenocarcinoma in patients who have had disease progression during or after prior systemic therapy.
In clinical trials, the NSCLC patient group experienced an overall response rate of 33% after being treated with the drug, while those with pancreatic cancer experienced an overall response rate of 40%.
“This approval is a testament to both our technology and strong execution as we continue to develop our multispecific platforms and pipeline, including our lead asset petosemtamab,” Chief Commercial Officer Shannon Campbell said in a press release.
The agency previously delayed its decision on the therapy to review additional chemistry, manufacturing and controls information. Originally, the FDA was slated to make its approval call by early November.
Meanwhile, Merus had been on the hunt for a commercialization partner since at least 2023, when it described a commercialization agreement as an “essential step” in getting the bispecific to patients with NRG1-positive cancer.
Monday, the drugmaker revealed a deal with Partner Therapeutics, giving the Massachusetts-based company an exclusive U.S. commercialization license in exchange for an undisclosed upfront payment plus potential milestone payouts and high single-digit to low double-digit royalty payments based on annual net sales.
Bizengri holds a boxed warning describing a risk of embryo-fetal toxicity. The drug should be available for intravenous use in the coming weeks, according to Merus. The drug will still have to prove itself in confirmatory trials given the nature of the accelerated approval.
While it hands commercialization responsibilities for Bizengri over to Partner, Merus is keeping busy with its petosemtamab. The company earlier this week dropped phase 2 data that bolster the candidate's potential to become “a new standard of care” for previously treated patients with recurrent/metastatic head and neck squamous cell carcinoma, Chief Medical Officer Fabian Zohren, M.D., Ph.D., said at the time.