MHRA-101159-PIP01-23

Key Facts

Active Substance
Active Substance:
  • MK 2870- Humanised IgG1 monoclonal antibody against TROP2, conjugated to a topoisomerase I inhibitor belotecan-derivative
Invented Name
Not yet available
PIP Number MHRA-101159-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • All pharmaceutical forms
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of lung cancer
  • Treatment of cervical cancer
  • Treatment of ovarian cancer
  • Treatment of endometrial cancer
  • Treatment of gastric cancer
  • Treatment of breast cancer
Route(s) of administration
Route(s) of administration:
  • All routes of administration
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):MK 2870- Humanised IgG1 monoclonal antibody against TROP2, conjugated to a topoisomerase I inhibitor belotecan-derivative.pdf
Published Date 03/10/2024