FDA Grants Breakthrough Status To Johnson & Johnson’s Cancer Drug For Advanced Head and Neck Cancer

Vandana Singh

Sun, February 22, 2026 at 1:31 AM GMT+9 3 min read

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The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for subcutaneous Rybrevant _Faspro (_amivantamab and hyaluronidase-lpuj) as a monotherapy for adults with advanced head and neck squamous cell carcinoma.

FDA Designation

The designation covers patients with cancer that is recurrent or metastatic and human papillomavirus (HPV)-unrelated after disease progression on or after platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.

Johnson & Johnson’s (NYSE:JNJ) announced Tuesday that Rybrevant _Faspro _is approved in multiple settings for locally advanced or metastatic non-small cell lung cancer and is also being evaluated in additional solid tumors, including colorectal cancer.

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The BTD is supported by data from the open–label Phase 1b/2 OrigAMI–4 study. Results were presented at the 2025 European Society for Medical Oncology (ESMO) Congress and demonstrate promising clinical activity, with rapid and durable responses, in a heavily pretreated patient population.

Subcutaneous amivantamab is being further evaluated in the ongoing Phase 3 OrigAMI-5 study, which is assessing the subcutaneous formulation of amivantamab in combination with Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab) and carboplatin versus 5-fluorouracil (5FU) plus pembrolizumab and platinum-based chemotherapy (cisplatin or carboplatin) for HPV-unrelated recurrent or metastatic head and neck squamous cell carcinoma, regardless of PD-L1 expression.

On Tuesday, the FDA approved a new, simplified monthly dosing schedule for Rybrevant Faspro in combination with oral Lazcluze (lazertinib) for the first-line treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer (NSCLC).

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Contract Extension

The U.K.-based Trellus Health plc inked a six-month contract extension with Johnson & Johnson’s (NYSE:JNJ) Health Care Systems unit to continue to provide Trellus Elevate, supporting patients with moderate to severely active inflammatory bowel disease (IBD) who are prescribed a Johnson & Johnson therapy for treatment of IBD.

A key factor in the extension was the achievement of engagement and satisfaction metrics during the initial pilot phase.

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Based on these metrics, Johnson & Johnson broadened the way patients can access the enrolment channels beyond the initial pilot funnel in mid-January 2026, reflecting continued confidence in the programme’s performance.

The collaboration was initially signed in January 2025, has been extended to mid-2026 with the same economic terms, including a fixed monthly management fee.

Trellus Health also continues to move forward with its TrialSet vertical, which is being deployed into agreed-upon sites with ICON plc (NASDAQ:ICLR) for an ongoing, mid-stage immunology and inflammation clinical trial sponsored by Takeda Pharmaceutical Co Ltd (NYSE:TAK).

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Trellus is also implementing TrialSet with PSI Inc. across two late-stage immunology and inflammation clinical trials sponsored by Sanofi SA (NASDAQ:SNY) and will be deployed into agreed-upon sites beginning mid of the second quarter.

“We are establishing a scalable go-to-market model for pharma, with continued focus on disciplined execution, recurring revenue growth, and expansion across immunology and inflammation. We look forward to updating the market on further developments,_” _commented **Marla Dubinsky, **CEO and Co-founder of Trellus Health.

Funding and Outlook

As previously disclosed, Trellus Health expects fiscal 2025 revenue to be approximately $545 thousand and has further reduced its monthly cash burn to around $400 thousand by late 2025 from around $440 thousand in October 2025.

This was moderately offset by recurring monthly management fees generated during the second half of the year.

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This article FDA Grants Breakthrough Status To Johnson & Johnson’s Cancer Drug For Advanced Head and Neck Cancer originally appeared on Benzinga.com

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