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.
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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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.
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.
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
