FDA approves TECVAYLI + DARZALEX FASPRO (ENHANZE) in r/r multiple myeloma
The FDA approved Halozyme’s DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) with ENHANZE for relapsed/refractory multiple myeloma on Mar 6, 2026. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Halozyme Therapeutics, Inc. HALO
- Drug
- DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) with ENHANZE
- For
- relapsed/refractory multiple myeloma
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Mar 6, 2026
- Source note
- Halozyme announced J&J won FDA approval for teclistamab plus DARZALEX FASPRO — which is co-formulated with Halozyme's rHuPH20/ENHANZE — in relapsed/refractory multiple myeloma after at least one prior line, based on Phase 3 MajesTEC-3.
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- Checked by a person when it was added
- Source: prnewswire.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- HALO headlines on this site
Halozyme expects the FDA to decide on amivantamab + hyaluronidase-lpuj (RYBREVANT FASPRO, uses Halozyme ENHANZE) for head and neck squamous cell carcinoma (OrigAMI-4) in Q1 2027 (Jan–Mar) (no exact date yet). An approval lets the company start selling it in that market.
More details
- Entry
- FDA decision on RYBREVANT FASPRO (ENHANZE) sBLA in head and neck cancer (partner: J&J) · Regulatory approval
- Drug
- amivantamab + hyaluronidase-lpuj (RYBREVANT FASPRO, uses Halozyme ENHANZE)
- For
- head and neck squamous cell carcinoma (OrigAMI-4)
- Stage
- sBLA under FDA priority review
- When
- Q1 2027 · the company gave a window, not a day
- Source note
- J&J submitted the sBLA around May 2026; Halozyme management said FDA granted priority review (~6-month review clock), implying a decision around late 2026/early 2027. No exact PDUFA date has been publicly announced.
- Checked
- Checked by a person when it was added
- Verify it
- Source: fool.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- HALO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
First Hypercon platform clinical trial starts, expected in the first half of 2027 (no exact date yet). A company milestone for Halozyme (Hypercon high-concentration formulation platform for undisclosed partner programs (incl. Vertex collaboration)): a step in the program rather than a decision or a data readout.
More details
- Entry
- First Hypercon platform clinical trial starts · Company milestone
- Drug
- Hypercon high-concentration formulation platform
- For
- undisclosed partner programs (incl. Vertex collaboration)
- Stage
- Clinical starts
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Halozyme management guidance on Q2 2026 call: "First Hypercon clinical starts in the first half of 2027."
- Checked
- Checked by a person when it was added
- Verify it
- Source: fool.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- HALO headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page