03.02.2025 14:52:58
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Halozyme Says CHMP Recommends Approval Of Subcutaneous Rybrevant Developed With ENHANZE In NSCLC
(RTTNews) - Janssen-Cilag International NV, a Johnson & Johnson company, received European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommendation for extension of marketing authorisation for a subcutaneous formulation of Rybrevant in combination with Lazcluze, Halozyme Therapeutics, Inc. (HALO) said in a statement on Monday. This formuation is used for the treatment of advanced epidermal growth factor receptor (EGFR) mutated non-small cell lung cancer (NSCLC).
Rybrevant has been developed with Halozyme's ENHANZE drug delivery technology.
The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study.

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