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News - TECVAYLI Plus DARZALEX FASPRO Combination Selected for National Priority Voucher Pilot Program

January 2026 | Katie Ogden, Portfolio Manager – Pharma, SAE Media Group

The supplemental Biologics License Application (sBLA) has been selected by the FDA for TECVAYLI (teclistamab-cqyv) in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) to participate in the Commissioner’s National Priority Voucher (CNPV) Pilot Program. The initiative aims to accelerate access to innovative therapies for patients in the United States.

“We are pleased the U.S. Food and Drug Administration (FDA) has selected the teclistamab MajesTEC-3 supplemental Biologics License Application (sBLA) to participate in the Commissioner’s National Priority Voucher (CNPV) Pilot Program as it aligns with the program’s priority to deliver more innovative therapies for American people. We look forward to working with the U.S. FDA to bring this transformational regimen to patients with multiple myeloma as soon as possible,” the company stated.

The sBLA is supported by Phase 3 MajesTEC-3 results showing TECVAYLI plus DARZALEX FASPRO significantly improved progression-free survival and overall survival compared to standard treatment after three years in patients with relapsed or refractory multiple myeloma. These findings were presented at the American Society of Hematology Annual Meeting and published in The New England Journal of Medicine. The FDA granted the combination Breakthrough Therapy Designation and is reviewing it under the Real-Time Oncology Review program.

About TECVAYLI
TECVAYLI is a first-in-class bispecific T-cell engager antibody that activates the immune system by binding to CD3 on T-cells and BCMA on multiple myeloma cells. It received accelerated FDA approval in October 2022 for adults with relapsed or refractory multiple myeloma after at least four prior lines of therapy. In February 2024, the FDA approved a reduced dosing frequency for patients achieving a complete response. Since launch, more than 20,800 patients worldwide have been treated with TECVAYLI.

About DARZALEX FASPRO
DARZALEX FASPRO is the only subcutaneous CD38-directed antibody approved for multiple myeloma. Approved in May 2020, it now has 11 indications, including frontline treatment. DARZALEX-based regimens have been used in more than 618,000 patients globally.

The FDA’s selection of this combination for the CNPV Pilot Program underscores its potential to redefine treatment standards for multiple myeloma.
 



WHAT IS CPD?

CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

CPD AND PROFESSIONAL INSTITUTES

There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

GLOBAL CPD

Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

CPD Certificates

We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

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