U.S. FDA Approves RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) Co-Formulated with Halozyme's ENHANZE® Technology for the Treatment of Advanced Head and Neck Cancer

The approval adds a subcutaneous treatment option using Halozyme's ENHANZE technology for eligible patients.

Rhea-AI Summary

Halozyme Therapeutics (HALO) announced FDA accelerated approval of Johnson & Johnson's RYBREVANT FASPRO for a defined group of head and neck cancer patients. The treatment combines amivantamab and hyaluronidase-lpuj with Halozyme's ENHANZE technology. Approval covers use as a single agent in adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody, a type of immunotherapy.

The indication excludes HPV-associated oropharyngeal squamous cell carcinoma, a cancer of the middle part of the throat. RYBREVANT FASPRO targets both epidermal growth factor receptor (EGFR) and mesenchymal-epithelial transition (MET). Johnson & Johnson issued its approval announcement on November 5, 2026.

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Positive

• Moderate pointFDA accelerated approval extends use of ENHANZE-co-formulated RYBREVANT FASPRO to eligible adults with advanced head and neck cancer.

Negative

• Minor pointApproved indication excludes patients with HPV-associated oropharyngeal squamous cell carcinoma.

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Market Reaction – HALO

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On Nov 6, the day this news came out, the latest delayed price for HALO is 15.36% below the previous close. Our momentum scanner has recorded 102 alerts for this stock so far that day. The latest delayed price is $104.07. Relative volume is very high at 4.4x what this stock usually trades by this time of day.

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Previous Fda approval Reports

1 past event · Latest: Dec 18

Same Type 1 event

1. Dec 18

   RYBREVANT approval

   24h Move

   -1.0%

   FDA approved the same RYBREVANT FASPRO-ENHANZE formulation for advanced EGFR-mutated non-small cell lung cancer.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

accelerated approval, hnscc, anti-pd-(l)1 antibody

3 terms

accelerated approval regulatory

"was granted accelerated approval from the U.S. Food and Drug Administration"

Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.

hnscc medical

"head and neck squamous cell carcinoma (HNSCC)"

HNSCC stands for head and neck squamous cell carcinoma, a type of cancer that starts in the flat lining cells that cover the surfaces of the mouth, throat and related structures. It matters to investors because treatments, clinical trial results, regulatory approvals or changes in diagnosis rates can directly affect the commercial prospects and valuation of companies developing therapies or diagnostics for this disease—think of it as a market signal tied to demand for specific medical products.

anti-pd-(l)1 antibody medical

"and an anti-PD-(L)1 antibody"

A monoclonal antibody that binds either the PD‑1 receptor (programmed death‑1) on immune T cells or its ligand PD‑L1 (programmed death‑ligand 1) on tumor or other body cells to block the PD‑1/PD‑L1 interaction. Blocking this immune checkpoint signal reduces inhibitory signaling on T cells and can restore or enhance T‑cell activity against cancer cells; anti‑PD‑1 antibodies target the receptor on T cells, while anti‑PD‑L1 antibodies target the ligand on tumor or accessory cells, a distinction that affects which ligand–receptor pairs are inhibited.

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Approval extends RYBREVANT FASPRO's well-established, dual-targeted benefit beyond lung cancer

SAN DIEGO, Nov. 6, 2026 /PRNewswire/ -- Halozyme Therapeutics, Inc. (Nasdaq: HALO) (Halozyme) today announced that Johnson & Johnson was granted accelerated approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE®, as a single agent for the treatment of adults with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose disease has progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. The indication does not include patients with oropharyngeal squamous cell carcinoma that is HPV-associated. It is the first approval of a dual-targeted therapy in this setting, simultaneously targeting epidermal growth factor receptor (EGFR)- and mesenchymal-epithelial transition (MET).

"This approval will further expand the reach of RYBREVANT FASPRO in a high unmet need population," said Dr. Helen Torley, President and Chief Executive Officer of Halozyme. "We are pleased that our ENHANZE technology is helping bring a new subcutaneous treatment option to patients with advanced head and neck cancer."

For more information on this approval, please view Johnson & Johnson's press release issued on November 5, 2026.

About Halozyme

Halozyme is a biopharmaceutical company advancing disruptive solutions to improve patient experiences and outcomes for emerging and established therapies. As the innovators of ENHANZE® drug delivery technology with the proprietary enzyme rHuPH20, Halozyme's commercially-validated solution is used to facilitate the subcutaneous delivery of injected drugs and fluids, with the goal of reducing treatment burden and improving convenience. ENHANZE® has touched more than one million patient lives through ten commercialized products across over 100 global markets and is licensed to leading pharmaceutical and biotechnology companies including Roche, Takeda, Pfizer, Janssen, AbbVie, Eli Lilly, Bristol-Myers Squibb, argenx, ViiV Healthcare, Chugai Pharmaceutical, Acumen Pharmaceuticals, Merus N.V., GSK, and Incyte.

Halozyme expanded its drug delivery technology portfolio to develop partner products using Hypercon™ and Surf Bio's hyperconcentration technology, recently renamed as Aerocon™. Hypercon™ is microparticle technology with the potential to set a new standard in hyperconcentration of drugs and biologics by reducing injection volume for the same dosage and enabling administration in at-home and healthcare-provider settings. The addition of Aerocon™ polymer-based hyperconcentration technology may further broaden the range of biologics that can be delivered subcutaneously. Together, we believe Hypercon™ and Aerocon™ technology complement ENHANZE® by enabling creation and delivery of highly concentrated biologics. The Hypercon™ technology has been licensed to leading biopharmaceutical partners, including Janssen, Eli Lilly, argenx, Vertex Pharmaceuticals, and Oruka Therapeutics.

Halozyme also develops, manufactures and commercializes drug-device combination products using advanced auto-injector technologies designed to improve convenience, reliability and tolerability, enhancing patient comfort and adherence. The Company has two proprietary commercial products, Hylenex® and XYOSTED®, partnered commercial products and ongoing development programs with Teva Pharmaceuticals and McDermott Laboratories Limited, an affiliate of Viatris Inc.

Halozyme is headquartered in San Diego, CA, with offices in Ewing, NJ; Minnetonka, MN; and Boston, MA. Minnetonka is also the site of its operations facility.

For more information, visit www.halozyme.com and connect with us on LinkedIn.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients, including a potential reduction in administration time and administration-related reactions, and broadening the treatment options for the indications referred to in this press release. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words "expect," "believe," "enable," "may," "will," "could," "intends," "estimate," "anticipate," "plan," "predict," "probable," "potential," "possible," "should," "continue," and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including unexpected results or delays in the launch or commercialization of our partner's product for the indication referred to in this press release, unexpected adverse events or patient experiences or outcomes from being treated with the ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme's most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

Contact:
Tram Bui
VP, Investor Relations and Corporate Communications
609-333-7668
tbui@halozyme.com

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SOURCE Halozyme Therapeutics, Inc.

FAQ

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What head and neck cancer use was approved for Halozyme's ENHANZE-co-formulated RYBREVANT FASPRO?

The FDA granted accelerated approval for RYBREVANT FASPRO as a single agent for adults with recurrent or metastatic head and neck squamous cell carcinoma whose disease progressed on or after platinum-based chemotherapy and an anti-PD-(L)1 antibody. Patients with HPV-associated oropharyngeal squamous cell carcinoma are excluded from the indication.