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PIPS Search Results
PIP Number	Active Substance	Conditions / Indications	Invented Name	Therapeutic area Sort descending	Decision Type	Compliance Check	Compliance outcome	Date Published
MHRA-100934-PIP01-23-M01 (update)	CARFILZOMIB	Treatment of acute lymphoblastic leukaemia	Kyprolis Kyprolis Kyprolis Kyprolis	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100985-PIP01-23-M01 (update)	BINIMETINIB	Treatment of melanoma	Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100986-PIP01-23-M01 (update)	ENCORAFENIB	Treatment of melanoma	Braftovi Braftovi Bravtovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		19/12/2023
MHRA-100642-PIP01-22-M02 (update)	Tremelimumab	Treatment of all conditions included in the category of malignant neoplasms (except central nervous system, haematopoietic and lymphoid tissue).	IMJUDO Tremelimumab AstraZeneca	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	19/12/2023
MHRA-100866-PIP01-23	obecabtagene autoleucel	Treatment of acute lymphoblastic leukaemia (ALL)		Oncology	P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)	No		30/01/2024
MHRA-100950-PIP01-23	lutetium-177 (177Lu) rhPSMA 10.1	Treatment of prostate cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/01/2024
MHRA-100117-PIP01-21-M03 (update)	ISATUXIMAB	Treatment of malignant neoplasms of the haematopoietic and lymphoid tissue	Sarclisa Sarclisa	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes		30/01/2024
MHRA-101131-PIP01-23-M01 (update)	BLINATUMOMAB	Treatment of acute lymphoblastic leukaemia	BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCTYO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO BLINCYTO	Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	Yes	Full Compliance Check Granted	30/01/2024
MHRA-100840-PIP01-23-M01 (update)	Odronextamab	Treatment of mature B cell malignancies		Oncology	PM: decision on the application for modification of an agreed paediatric investigation plan.	No		30/01/2024
MHRA-100858-PIP01-23	sabatolimab	Treatment of myelodysplastic syndromes		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/01/2024
MHRA-101034-PIP01-23	Belrestotug GSK4428859A	Treatment of lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/01/2024
MHRA-100969-PIP01-23	V940 (mRNA-4157), Modified messenger ribonucleic acid encoding individual patient-specific tumour neoantigens	Treatment of lung cancer	Not available at present	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100980-PIP01-23	1-((S)-4-((R)-7-(6-amino-4-methyl-3-(trifluoromethyl)pyridin-2-yl)-6-chloro-8-fluoro- 2-(((S)-1-methylpyrrolidin-2-yl)methoxy)quinazolin-4-yl)-3-methylpiperazin-1-yl)prop- 2-en-1-one adipate	Treatment of non-small cell lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101059-PIP01-23	[(2R)-2,3-bis[[(Z)-octadec-9-enoyl]oxy]propyl]-trimethylazanium chloride (R-DOTAP chloride) Palmitoyl-KSS-MHGDTPTLHEYMLDLQPETT (HPV-16 E7 1-20) / Palmitoyl-KSS-YMLDLQPETT (HPV-16 E7 11-20) / Palmitoyl-KSS-GQAEPDRAHYNIVTF (HPV-16 E7 43-57) / Palmitoyl-KSS-KKLLMGTLGIVCPICSQKP(HPV-16 E7 82-98) / Palmitoyl-KSS-LLMGTLGIV (HPV-16 E7 82-90) /Palmitoyl-KSS-ELQTTIHDIILECVYCKQQLL (HPV-16 E6 25-45)	Treatment of human papilloma virus (HPV) type 16 positive malignancies		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101090-PIP01-23	tiragolumab	Treatment of hepatocellular carcinoma		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100985-PIP02-23	BINIMETINIB	Treatment of lung cancer	Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi Mektovi	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-100986-PIP02-23	ENCORAFENIB	Treatment of lung cancer	Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi Braftovi	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101085-PIP01-23	Humanised IgG1 monoclonal antibody against integrin beta-6 conjugated to monomethyl auristatin E via a valine-citrulline linker	Treatment of non-small cell lung cancer		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101100-PIP01-23	Derivative of a benzoimidazole substituted pyrimidine (PF-07220060)	Treatment of breast malignant neoplasms		Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024
MHRA-101122-PIP01-23	ENFORTUMAB VEDOTIN	Treatment of head and neck epithelial malignant neoplasms	Padcev Padcev Padcev	Oncology	W: decision granting a waiver in all age groups for the listed condition(s).	No		30/04/2024

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