Boehringer Ingelheim GmbH won approval in the U.S. for its drug to treat a challenging form of lung cancer, offering a growth avenue for the privately-held German pharmaceuticals company.
The drug, called zongertinib, can now be used on patients with HER2-mutant non-small cell lung cancer who have already received chemotherapy, according to a statement. The patients, whose tumors either can’t be completely surgically removed or whose cancer has already spread, currently have few options and low survival rates.
About 3% of non-small cell lung cancer patients have HER2 mutations. For now, the only competing product is Enhertu, an intravenously administered antibody-drug conjugate from AstraZeneca Plc and Daiichi Sankyo. By contrast, Boehringer’s small-molecule medicine — with the brand name Hernexeos — comes in the form of orally administered tablets that patients can take at home with a generally manageable safety profile.
“This can be a game changer for patients and truly change clinical practice,” Boehringer Chief Executive Officer Shashank Deshpande said in an interview.
The U.S. Food and Drug Administration approved the medicine on an accelerated basis, meaning that its effectiveness may need to be confirmed in further clinical settings.
Boehringer is Germany’s largest pharma company by revenue, with sales of its medicines for humans reaching €21.9 billion ($25.7 billion) in 2024, according to its website. The company also has a smaller division focused on medicines for animals.
Given the lack of competition in this space, doctors will probably want to adopt zongertinib quickly and Boehringer could see global sales exceed $300 million by 2030, said Javier Manso Polo, an analyst at Bloomberg Intelligence, in an interview. Ultimately, doctors may want to combine therapies like Boehringer’s with others like Enhertu, expanding treatment options, Polo said in a recent note.
The German company is working on further clinical trials in hopes of treating patients with zongertinib as a first line of defense.
“Given the success we have seen in second line or previously treated patients, we are eager to get also the first line indication,” Deshpande said.
Fellow German pharma company Bayer AG has a similar therapy, called sevabertinib, currently being reviewed by regulators. It has also demonstrated promising efficacy and safety data, according to Polo.
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