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PIP Number Active Substance Conditions / Indications Invented Name Therapeutic area Decision Type Compliance Check Compliance outcome Date Published
MHRA-101663-PIP01-24
  • AMIVANTAMAB
  • Treatment of colorectal carcinoma
  • Rybrevant
  • Rybrevant
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101591-PIP01-24
  • SACITUZUMAB GOVITECAN
  • Treatment of endometrial cancer
  • Trodelvy
  • Trodelvy
  • Trodelvy
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101548-PIP01-24
  • Xaluritamig
  • Treatment of prostate malignant neoplasms.
  • Not available yet
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101049-PIP01-23
  • retifanlimab
  • Treatment of Merkel cell carcinoma
  • ZYNYZ
  • retifanlimab
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101588-PIP01-24
  • Derivative of 1,5,6,7-tetrahydro-4H-pyrrolo[3,2-c]pyridin-4-one
  • Treatment of lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101586-PIP01-24
  • Ifinatamab deruxtecan
  • Treatment of lung cancer (small cell and non-small cell lung cancer)
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101581-PIP01-24
  • rinatabart sesutecan
  • Treatment of Ovarian cancer
  • Treatment of fallopian tube cancer
  • Treatment of peritoneal cancer.
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101570-PIP01-24
  • firmonertinib
  • Treatment of non-small cell lung cancer (NSCLC)
  • firmonertinib
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101564-PIP01-24
  • (5aSa,17aRa)-20-Chloro-2-[(2S,5R)-2,5-dimethyl-4-(prop-2-enoyl)piperazin-1-yl]-14,17-difluoro-6-(propan-2-yl)-11,12-dihydro-4H-1,18-(ethanediylidene)pyrido[4,3-e]pyrimido[1,6- g][1,4,7,9]benzodioxadiazacyclododecin-4-one (MK-1084)
  • Treatment of all solid and haematological malignancies
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101525-PIP01-24
  • Actinium-225-2-(4,7,10-tris-carboxymethyl-1,4,7,10 tetraaza-cyclododec-1-yl)-pentanedioic acid 3-iodo-D-Tyr-D-Phe-D-Lys-OH)-8-oyl-ε-(HO-Glu-ureido-Lys-OH)
  • Treatment of PSMA-expressing prostate cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101106-PIP01-23
  • LY3884963 (PR006A)
  • Treatment of frontotemporal dementia
  • Neurology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101572-PIP01-24
  • Nogapendekin alfa
  • Inbakicept
  • Treatment of malignant bladder neoplasms
  • ANKTIVA
  • ANKTIVA
  • Uro-Nephrology
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101465-PIP01-24
  • anitocabtagene autoleucel
  • Treatment of multiple myeloma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101547-PIP01-24
  • IgG-like T cell engager binding to DLL3 and CD3
  • Treatment of small cell lung carcinoma
  • Treatment of neuroendocrine carcinoma, (excluding neuroblastoma)
  • Not available at present
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101523-PIP01-24
  • Raludotatug deruxtecan
  • Treatment of Ovarian cancer
  • Treatment of fallopian tube cancer
  • Treatment of primary peritoneal cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101506-PIP01-24
  • Zongertinib
  • Treatment of non-small cell lung cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101442-PIP01-24
  • Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens V940 (mRNA-4157)
  • Treatment of urothelial carcinoma
  • Treatment of cutaneous squamous cell carcinoma
  • Treatment of renal cell carcinoma
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101384-PIP01-24
  • Telisotuzumab adizutecan
  • Treatment of colorectal carcinoma.
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101500-PIP01-24
  • Zanidatamab
  • Treatment of gastroesophageal adenocarcinoma (GEA).
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
MHRA-101499-PIP01-24
  • Zanidatamab
  • Treatment of HER2-positive breast cancer
  • Oncology
 W: decision granting a waiver in all age groups for the listed condition(s). No
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