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ogivri

ogivri: sourced relationships with 1 company · 1 FDA decision.

ogivri evidence translation

What we can confirm

What it means

Source-backed records connect ogivri to MYL; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could ogivri → MYL affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

Dated Pipeline Records (1)
CompanyDated record stage
Mylan II B.V. (MYL)
Reported 2017-12-01 · Current development: unknownSource
Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE Ogivri is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.2 ). 1.1 Adjuvant Breast Cancer Ogivri is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or no(MYL)FDA ↗
BLA761074UNKNOWNStandardOtherInjectable

Frequently asked questions

Which companies have sourced relationships with ogivri?

ogivri has dated SEC/FDA relationship records for Mylan II B.V..

What is ogivri's latest FDA decision?

The most recent tracked FDA decision for ogivri is Approval for 1 INDICATIONS AND USAGE Ogivri is a HER2/neu receptor antagonist indicated in adults for: The treatment of HER2-overexpressing breast cancer. ( 1.1 , 1.2 ) The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. ( 1.3 ) Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product ( 1 , 2.2 ). 1.1 Adjuvant Breast Cancer Ogivri is indicated in adults for adjuvant treatment of HER2 overexpressing node positive or no, dated December 1, 2017.