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Herceptin Hylecta FDA Approval History

FDA Approved: Yes (First approved February 28, 2019)
Brand name: Herceptin Hylecta
Generic name: trastuzumab and hyaluronidase-oysk
Dosage form: for Subcutaneous Injection
Company: Genentech, Inc.
Treatment for: Breast Cancer

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) is a combination of the approved HER2/neu receptor antagonist trastuzumab (Herceptin) and recombinant human hyaluronidase PH20 (an enzyme that helps to deliver trastuzumab under the skin) indicated for the treatment of HER2-overexpressing breast cancer.

Development timeline for Herceptin Hylecta

Feb 28, 2019Approval FDA Approves Herceptin Hylecta for Subcutaneous Injection in Certain HER2-Positive Breast Cancers

Further information

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