The FDA has “proactively” granted Johnson & Johnson a coveted speedy review under the Commissioner’s National Priority Voucher pilot (CNPV), the agency said Monday.
The voucher was granted to J&J for its proposed combination of Tecvayli and Darzalex for previously treated multiple myeloma.
With the voucher, the FDA aims to deliver a decision within one to two months following submission of an application. Normally, FDA drug reviews take up to 10 months, starting from the acceptance of an application.
The announcement comes less than a week after results from the phase 3 MajesTEC-3 trial for the combo were presented at the American Society of Hematology annual meeting in Orlando. In revealing what it called “unprecedented” results, J&J said in a Dec. 9 release that it had submitted an application for Tecvayli and Darzalex for the multiple myeloma indication, which was being assessed under the real-time oncology review pathway. The headline trial data were first released in a conference abstract on Nov. 24.
According to the FDA, the company didn’t initially seek out a CNPV.
“Within hours of the trial results being published 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,” FDA Commissioner Martin Makary, M.D., said in a Dec. 15 statement. “When a treatment demonstrates outstanding trial results, we have a duty to patients to move swiftly.”
The MajesTEC-3 trial showed that the Tecvayli-Darzalex combo reduced the risk of death by 54% over traditional combo regimens, including Darzalex and dexamethasone with either Bristol Myers Squibb’s Pomalyst or Takeda’s Velcade, among multiple myeloma patients who had tried one to three prior lines of therapy. The new J&J cocktail’s progression-free survival advantage reached a staggering 83%.
What’s more, the flattening of the combo’s overall survival curve—which visualizes a trial’s patient death events—suggests its potential to be a functional cure for patients.
In a Dec. 9 note, Leerink Partners analysts called the MajesTEC-3 results “exceptional.” However, the exclusion of patients who were refractory to Darzalex—which has become a standard first-line therapy with increased adoption—was a weak point in the data set, the analysts said.
The strong data may prompt some doctors to assume that the efficacy profile also applies to those CD38-refractory patients, but other doctors and regulators will worry that only 5% of the MajesTEC-3 patients had previously received Darzalex, the Leerink team added.
In a statement to Fierce Pharma, J&J the said the company is pleased with the FDA’s selection of the MajesTEC-3 regimen for CNPV “as it aligns with the program’s priority to deliver more innovative therapies for American people.”
The CNPV granted to Tecvayli-Darzalex marks the 16th of its kind since the program's introduction earlier this year. The first CNPV-based FDA go-ahead just went to USAntibiotics and its domestically manufactured extended-release antibiotic, Augmentin XR, although the exact context of the approval was unclear. The pilot program is meant to prioritize drugs that follow certain U.S. national priorities, such as “delivering more innovative cures” and onshoring of drug development and manufacturing, among others.
But questions have been raised about the initiative's legality and the robustness of the FDA’s evaluation of these drugs.
Meanwhile, the review of the J&J regimen comes as Richard Pazdur, M.D., the long-time head of the FDA’s oncology department, is set to retire from the agency. He is leaving after a short stint as director of the FDA’s Center for Drug Evaluation and Research, following a reported disagreement with Makary on the CNPV program.
“FDA’s reviewers apply the same standards and processes to all applications, and efforts to improve efficiency through the CNPV program do not alter the agency’s independence or its commitment to rigorous review,” a health department spokesperson said in a previous statement to Fierce.