Home

News - FDA Grants Breakthrough Therapy Designation to RYBREVANT FASPRO for Advanced Head and Neck Cancer

February 2026 | Katie Ogden, Portfolio Manager – Pharma, SAE Media Group
Johnson and Johnson announced, on Feb. 18, 2026, that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to subcutaneous amivantamab and hyaluronidase-lpuj for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma that is unrelated to human papillomavirus and has progressed following platinum-based chemotherapy and PD-1 or PD-L1 inhibitor treatment.

The designation applies to the use of the therapy as a monotherapy in patients with advanced disease who have limited treatment options after prior lines of therapy. RYBREVANT FASPRO is currently approved in multiple settings for locally advanced or metastatic non-small cell lung cancer and is also being studied in other solid tumors, including colorectal cancer.

HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma is often associated with high expression of the epidermal growth factor receptor and overexpression of the mesenchymal-epithelial transition pathway. Subcutaneous amivantamab is designed to target both pathways while also activating immune system responses. According to the company, early clinical findings support continued investigation of this approach in a disease area where outcomes remain poor following standard therapies.

“Patients with HPV-unrelated recurrent or metastatic head and neck cancer often face rapid disease progression and have limited treatment options,” said Kiran Patel, Vice President and Global Head of Solid Tumor Clinical Development and Diagnostics at Johnson and Johnson. “Receiving Breakthrough Therapy Designation underscores the FDA’s recognition of these early clinical data and the urgent need for new therapies. Dual targeting EGFR and MET has shown meaningful clinical benefit in lung cancer, helping patients live longer by changing disease biology and preventing treatment resistance. We are now applying this same multi-targeted approach in head and neck cancer with the goal of improving outcomes for patients.”

The FDA’s decision was supported by data from the open-label Phase 1b/2 OrigAMI-4 study. Results were presented at the 2025 European Society for Medical Oncology Congress and showed rapid and durable responses in a heavily pretreated patient population. Based on these findings, subcutaneous amivantamab is now being further evaluated in the ongoing Phase 3 OrigAMI-5 trial. That study is comparing the subcutaneous formulation in combination with pembrolizumab and carboplatin against a regimen of 5-fluorouracil plus pembrolizumab and platinum-based chemotherapy as a first-line treatment, regardless of PD-L1 expression.

Breakthrough Therapy Designation is intended to speed the development and review of medicines for serious or life-threatening conditions when early clinical evidence suggests the therapy may offer substantial improvement over existing treatment options on clinically meaningful endpoints.

Head and neck squamous cell carcinoma accounts for more than 90 percent of head and neck cancers worldwide. Approximately three-quarters of cases are HPV-negative, a subgroup that is generally associated with poorer prognosis and reduced response to treatment. Despite advances in available therapies, many patients ultimately develop recurrent or metastatic disease.
 



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

Event Title

Headline

Text
Read More

I would like to speak at an event

I would like to attend an event

Group Booking

Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

I would like to sponsor/exhibit at an event

SIGN UP OR LOGIN

Sign up
Forgotten Password?

Contact SAE Media Group

UK Office
Opening Hours: 9.00 - 17.30 (local time)
SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
Website: http://www.smgconferences.com Email: events@saemediagroup.com
Registered in England - SMi Group Ltd trading as SAE Media Group




Forgotten Password

Please enter the email address you registered with. We will email you a new password.

Thank you for visiting our event

If you would like to receive further information about our events, please fill out the information below.

By ticking above you are consenting to receive information by email from SAE Media Group.
Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
Should you wish to update your contact preferences at any time you can contact us at data.privacy@smgconferences.com.
Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

Fill in your details to download the brochure

By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.

Join the Loitering Munitions community

Keep up to date with industry news, insights, and community updates FREE and direct to your inbox every month!
* - required fields
You can unsubscribe at any time. For full details see our Privacy Policy

Download the 2026 Defence Events Calendar here to view the full list of SAE Media Group’s conferences this year

By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.