FDA Grants National Priority Certificate to Teritusumab Plus Daratumumab for the Treatment of Relapsed/Refractory Multiple Myeloma

The FDA granted National Priority Warrant for teritusumab (Teclistamab-cqyv) in combination with daratumumab (Darzalex; Johnson & Johnson) for the treatment of relapsed/refractory multiple myeloma (MM). This action brings the total number of products awarded under the Commissioner's National Priority Voucher (CNPV) pilot program to 16.1, according to a news release from the agency.

What isCNPV Pilot Program?

According to the FDA, the CNPV pilot program announced in June 2025 provides an opportunity to reduce the review time for drug and biologic product applications or efficacy supplements (ES) from 10 to 12 months to 1 to 2 months. The program utilizes a collaborative tumor board-style review process to expedite approval of companies that align with key U.S. national health priorities. Those selected for the program will receive a voucher that entitles the company to benefits, including enhanced communication and rolling reviews to shorten review times.

The CNPV pilot program reflects FDA's broader commitment to create more efficient approval processes and modernize the regulatory framework to be more flexible in meeting emerging public health needs. Teritusumab joins 15 other therapies added to the CNPV program. To date, other drugs that have received vouchers include:

Zongertinib (Hernexeos; Boehringer Ingelheim) treats HER2 lung cancer;

Bedaquiline (Sirturo; Janssen Biotech) treats drug-resistant tuberculosis in young children;

Dostarlimab (Jemperli; GSK) for rectal cancer;

Exagamglogene autotemcel (Casgevy; Vertex Pharmaceuticals) for sickle cell disease

Orforglipron (Eli Lilly) for obesity and related health conditions;

Semaglutide (Wegovy; Novo Nordisk) for obesity and related health conditions;

Follitropin alfa/lutropin alfa (Pergoveris; Merck) treats infertility;

Teplizumab (Tzield; Sanofi) treats type 1 diabetes;

DB-OTO (Regeneron) treats deafness;

Cenegermin bkbj (Oxervate; Dompéfarmaceutici SpA) for blindness;

Daraxonrasib (RMC-6236; Revolution Medicines) to treat pancreatic cancer;

Bitopertin (DISC-1459; DISC Medicine) treats porphyria;

What supports this action?

This action follows the recent release of data from the Phase 3 MajesTEC-3 clinical trial (NCT05083169), a randomized study comparing subcutaneous teritusumab plus daratumumab to daratumumab , pomalidomide (Pomalyst; Bristol-Myers Squibb) and dexamethasone (DPd) or daratumumab, bortezomib (Velcad; Takeda Oncology) and dexamethasone (DVd). A total of 587 patients with relapsed/refractory multiple myeloma who had received one to three prior lines of therapy were randomly assigned to receive Tec-Dara (n=291), DPd, or DVd (n=296 between groups).

At a median of approximately34.5 months, Tec-Dara had significantly longer progression-free survival (PFS) than DPd or DVd. Estimated 36-month PFS was approximately 83.4% for patients who received Tec-Dara compared with 29.7% in the DPd or DVd group (HR, 0.17 [95% CI, 0.12-0.23]; P<0.001). Additionally, more patients in the Tec-Dara group than in the DPd or DVd groups had complete responses or better (81.8% vs. 32.1%, respectively), overall responses (89.0% vs. 75.3%), and negative minimal residual disease (10-5; 58.4% vs. 17.1%; P<0.001 for all comparisons). Approximately 70.7% of patients in the Tec Dara group experienced serious adverse events (AE), and approximately 62.4% of the patients in the DPd or DVd group experienced serious adverse events (AE). The incidence of death related to AEs was 7.1% and 5.9%, respectively.

References: UpdatedDecember 16, 2025, https://www.pharmacytimes.com/view/fda-awards-national-priority-voucher-to-teclistamab-plus-daratumumab-in-relapsed-refractory-multiple-myeloma