Boehringer Wins Speedy Lung Cancer Approval Under Commissioner’s Priority Program

 

Hernexeos is the second drug to secure an FDA approval under the agency’s priority voucher scheme, following in the footsteps of USAntibiotics’ Augmentin XR, which was granted the ticket in December 2025.

Just six weeks after receiving an application, the FDA has handed out an accelerated approval to Boehringer Ingelheim’s Hernexeos, allowing its use in patients with unresectable or metastatic non-small cell lung cancer carrying certain mutations.

The approval, granted Thursday, is the second to come under the regulator’s new Commissioner’s National Priority Voucher (CNPV) program. The first was given to generics maker USAntibiotics in December 2025 for the antibiotic Augmentin XR. CNPV tickets are awarded to companies that align with certain national priorities set by the government. When used, the vouchers can shave review times from 10-12 months to 1-2 months.

Boehringer received the CNPV for Hernexeos in November 2025 and filed its drug application on Jan. 13, 2026.

Hernexeos’ data package included results from the Phase 1b Beamion LUNG-1 study, which found a 76% overall response rate in treatment-naïve patients, Boehringer said Thursday in its own announcement of the approval. In its news release, the FDA called this effect “remarkable.”

Beamion LUNG-1 also found that 64% of treated patients had responses lasting 6 months or longer.

Taken orally, Hernexeos is a kinase blocker that targets HER2 to suppress the proliferation of cancer cells. The drug was first cleared in August last year for previously treated patients with HER2-mutated NSCLC. Thursday’s approval expands Hernexeos’ coverage to those who had not yet been treated.

Both of Hernexeos’ indications were granted under the FDA’s accelerated pathway, and Boehringer will need to validate its clinical benefits in a confirmatory study to maintain the approvals.

The CNPV program has attracted criticism. Earlier this month, Rep. Jake Auchincloss (D-MA) wrote to the regulator and flagged the scheme’s lack of transparency.

“The public must have transparency about the ‘voucher’ program, under which drug approvals have been made almost wholly and in an unprecedented manner by the FDA’s political leadership,” Auchincloss wrote, noting that the FDA has failed to respond to several congressional inquiries about the program.

A few days later, the regulator declined to approve Disc Medicine’s bitopertin for the rare blood disorder erythropoietic protoporphyria—a decision that has attracted scrutiny given reports that Vinay Prasad, director of the Center for Biologics Evaluation and Research, had been skeptical of the drug.

Bitopertin had also been awarded a CNPV, and its rejection, which came after four months instead of the advertised one to two months, “reads negatively to the broader CNPV program,” BMO Capital Markets said in a Feb. 13 note to investors. “Selection does not guarantee 1) faster reviews; or 2) approval.”

https://www.biospace.com/fda/boehringer-wins-speedy-lung-cancer-approval-under-commissioners-priority-program