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Forthcoming Submissions:

PACE medicines

Name Manufacturer Submission Type Patient Group Submission Deadline SMC Meeting Date Advice Due
atezolizumab (Tecentriq) for NSCLC Roche Full submission 2/04/2018 Q2 2018 Q3 2018
atezolizumab (Tencentriq) Roche Full submission 4/12/2017 6/02/2018 12/03/2018
avelumab (Bavencio) Merck Serono Europe Limited / Pfizer Limited Full submission 5/02/2018 Q2 2018 Q2 2018
conestat alfa (Ruconest) Pharming Group NV Full submission TBC TBC TBC
crizotinib (Xalkori) Pfizer Ltd Full submission 5/03/2018 Q2 2018 Q2 2018
everolimus (Votubia) Novartis Pharmaceuticals UK Ltd Full submission 5/03/2018 Q2 2018 Q2 2018
glycerol phenylbutyrate (Ravicti) Janssen-Cilag Ltd Full submission TBC TBC TBC
inotuzumab ozogamicin (Besponsa) Pfizer Ltd Full submission 5/03/2018 Q2 2018 Q2 2018
letermovir (Prevymis) MSD Full submission 2/04/2018 Q2 2018 Q3 2018
lutetium 177Lu oxodotreotide (Lutathera) Advanced Accelerator Applications Full submission 2/04/2018 Q2 2018 Q3 2018
midostaurin (Rydapt) for AML Novartis Pharmaceuticals UK Ltd Full submission 5/03/2018 Q2 2018 Q2 2018
niraparib tosylate monohydrate (Zejula) Tesaro UK Ltd Full submission TBC TBC TBC
nusinersen (Spinraza) Biogen Idec Ltd Full submission 5/02/2018 Q2 2018 Q2 2018
pembrolizumab (Keytruda) (cHL) MSD Full submission 4/12/2017 6/02/2018 12/03/2018
pembrolizumab (Keytruda) (urothelial carcinoma) MSD Full submission 2/04/2018 Q2 2018 Q3 2018
regorafenib (Stivarga) Bayer Plc Full submission 5/02/2018 Q2 2018 Q2 2018
ribociclib (Kisqali) Novartis Pharmaceuticals UK Ltd Full submission 4/12/2017 6/02/2018 12/03/2018
teduglutide (Revestive) Shire Pharmaceuticals Full submission 6/11/2017 9/01/2018 9/04/2018
telotristat (Xermelo) Ipsen Ltd Full submission 5/03/2018 Q2 2018 Q2 2018
tivozanib (Fotivda) EusaPharma Full submission 2/04/2018 Q2 2018 Q3 2018

Non-PACE medicines

Name Manufacturer Submission Type Patient Group Submission Deadline SMC Meeting Date Advice Due
asparaginase (Spectrila) Medac Pharmaceuticals Abbreviated Submission N/A 6/03/2018 9/04/2018
brodalumab (Kyntheum) LEO Pharmaceuticals Resubmission 5/03/2018 3/04/2018 7/05/2018
ciprofloxacin hydrochloride (Cetraxal) Aspire Pharma Ltd Abbreviated Submission N/A 6/03/2018 9/04/2018
dimethyl fumarate (Skilarence) Almirall Ltd Full submission 5/02/2018 6/03/2018 9/04/2018
guselkumab (Tremfya) Janssen-Cilag Ltd Full submission 2/04/2018 1/05/2018 11/06/2018
icatibant (Firazyr) Shire Pharmaceuticals Abbreviated Submission N/A 3/04/2018 7/05/2018
ledispavir / sofosbuvir (Harvoni) Gilead Sciences Ltd Abbreviated Submission TBC TBC TBC
ocrelizumab (Ocrevus) Roche Full submission TBC TBC TBC
sarilumab (Kevzara) Sanofi Genzyme Full submission 5/02/2018 6/03/2018 9/04/2018
selexipag (Uptravi) Actelion Pharmaceuticals UK Ltd Resubmission 5/03/2018 3/04/2018 7/05/2018
sofosbuvir / velpatasvir (Epclusa) Gilead Sciences Ltd Resubmission 5/02/2018 6/03/2018 9/04/2018
sofosbuvir/velpatasvir/voxilprevir (Vosevi) Gilead Sciences Ltd Full submission 5/02/2018 6/03/2018 9/04/2018

Medicines with advice withheld pending product availability

Name Manufacturer Submission Type Patient Group Submission Deadline SMC Meeting Date Advice Due
afamelanotide (Scenesse) Clinuvel (UK) Ltd Full submission 1/05/2017 4/07/2017 TBC
empaglifozin linagliptin fixed-dose combination (Glyxambi) Boehringer Ingelheim Ltd Abbreviated Submission N/A 4/04/2017 TBC
oritavancin (Orbactiv) The Medicines Company Full submission 2/11/2015 1/12/2015 TBC

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