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biotech/news//The Hindu
Boehringer Ingelheim's zongertinib is approved as a first-line treatment for a rare form of non-small cell lung cancer.
Hernexeos is now FDA-approved as a first-line treatment for untreated NSCLC with a rare mutation.
KEY POINTS
The FDA granted approval 44 days after filing, under the new National Priority Voucher Program.
First-line approval allows Boehringer to potentially double its addressable market for Hernexeos.
In clinical studies, Hernexeos shrank tumors in 76% of untreated NSCLC patients with the rare mutation.
The U.S. Food and Drug Administration on Thursday approved Boehringer Ingelheim's zongertinib as a first-line treatment for a rare form of non-small cell lung cancer, making it the second drug to be cleared under the agency's new speedy review program.
Zongertinib, sold as Hernexeos, is now approved for previously untreated patients with NSCLC whose tumors carry a rare genetic mutation found in about 3% to 5% of such cases.
It was approved last year for patients whose cancer advanced or spread despite earlier treatments.
The first-line approval would allow Boehringer to target the entire patient population, potentially doubling its addressable market, Itziar Canamasas, the company's global head of oncology, told Reuters ahead of the decision.
Canamasas added that the early use of the drug could offer patients a more convenient, tolerable and efficacious treatment option.
The approval expands Boehringer's position in the market for targeted lung cancer therapies. It will compete with other treatments, including Bayer's Hyrnuo.
Boehringer's Hernexeos was one of the 18 drugs selected so far for the FDA Commissioner's National Priority Voucher Program that allows speedy process and cuts the review time to one to two months from the typical 10 to 12 months.
The decision on Hernexeos came 44 days after the filing date, FDA Commissioner Marty Makary said.
The FDA approved USAntibiotics' Augmentin XR under the expedited program in December. However, several major drugmakers have avoided the program due to worries that approvals granted under the pathway could face legal challenges.
The approval was based on a study in which zongertinib helped about 76% of previously untreated patients achieve a substantial decrease in tumor size, compared to 30%-45% of patients for the current standard of care, the FDA said.
Boehringer's Hernexeos belongs to a class of drugs called tyrosine kinase inhibitors that selectively inhibit protein kinases that regulate cell growth.