FDA proactively reached out to Janssen to offer a CNPV voucher for Tec-Dara
Instead of waiting for the sponsor to submit a request, the US Food and Drug Administration (FDA) proactively added the cancer drug combination teclistamab plus daratumumab to its Commissioner's National Priority Voucher pilot program. The agency stated that the initial trial results were very promising, prompting regulators to offer a voucher to expedite its pathway to market.On 15 December, the FDA announced that it had added Janssen Pharmaceuticals’ teclistamab plus daratumumab (Tec-Dara) to treat patients with relapsed/refractory multiple myeloma to its CNPV pilot program before the company asked to be added. The agency stated that, after reviewing the promising results of a Phase 3 clinical trial, which were initially released on 24 November and published in the New England Journal of Medicine (NEJM) on 9 December, the agency contacted the researchers to add the drug to the CNPV pilot program.
“We’re on a mission to deliver more cures and meaningful treatments to the American people,” said FDA Commissioner Marty Makary, in an agency statement. “This means proactively identifying potentially transformative therapies. Within hours of the trial results being in the American Society of Hematology conference program, FDA leaders read the study, consulted with internal experts, and the following day contacted the company to discuss a national priority voucher. When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly.”
The FDA said that the trial showed the drug combination resulted in significant improvements over the standard of care in both progression-free survival and overall survival in patients who had previously received one to three prior lines of therapy. The agency also noted that 80% of patients remained free of disease progression three years after treatment.
Former FDA Commissioner Robert Califf told Focus that it's difficult to judge how the agency's decision on Tec-Dara will play out without knowing more details, but he agreed that patients should have access to the drug combination as soon as possible if it is as promising as it appears.
"This one hits close to home," he added. "My mom got a few extra good years on daratumamab with its initial accelerated approval."
Califf cautioned that, despite the promising data shown in the NEJM article, the data ultimately submitted to the FDA may differ from what is presented at medical conferences and published in scientific journals, which is why the agency has traditionally been cautious about preliminary data. He also noted it will take a lot of time to ensure the agency gets the labeling, manufacturing, and details of the data right.
"Some will worry that the FDA appears to be promoting a drug as opposed to letting the manufacturer(s) do that, but this particular one doesn’t seem too risky," said Califf.
In June, the FDA announced the CNPV pilot program, where sponsors can get a dramatically accelerated review of their investigational new drugs – in 1-2 months instead of 10-12 – if their drug can address significant unmet needs and is considered critical to national security, among other criteria. By November, the agency announced it had added 15 drugs to the pilot program. Tec-Dara is now number 16 (RELATED: Makary says FDA is ‘strong’ despite recent leadership turmoil, Regulatory Focus, 6 November 2025).
FDA announcement
