Pharma Update
Roche
2023: Key late-stage newsflow*
Regulatory
Compound
Hemlibra
Polivy + R-CHP
Vabysmo
Tecentriq
Columvi (glofitamab)
Xofluza
Tecentriq + Avastin
Tecentriq + chemo
Tecentriq
Tecentriq + chemo
Tiragolumab + Tecentriq
Tiragolumab + Tecentriq + chemo
Venclexta + dexamethasone
Venclexta + azacitidine
Alecensa
Indication
Moderate hemophilia A
1L DLBCL
RVO
Subcutaneous administration
3L+ DLBCL
Influenza (paediatric 1+ yrs.)
Adjuvant HCC
Neoadjuvant/adjuvant TNBC
Adjuvant SCCHN
Adjuvant TNBC
1L PDL 1+ NSCLC
1L esophageal cancer
t(11;14) R/R MM
1L high risk MDS
Milestone
EU approval
US approval
US approval/EU filing
US approval/EU filing
US/EU approval
EU approval
Ph III IMbrave050
Ph III IMvoke010
Ph III IMpassion030
EU filing
US 2024/ EU filing
Ph III GeparDouze/NSABP B-59
2024
Х
Q4 2023/Q1 2024
Ph III SKYSCRAPER-08 (China only)
Ph III CANOVA
Ph III SKYSCRAPER-01
2024
Phase III/ pivotal
readouts
Phesgo OBI (on body injector)
Crovalimab
Columvi + GemOx
Lunsumio + Polivy
Elevidys (Delandistrogene moxeparvovec)
Ocrevus 6m SC
TNKase
Susvimo
Susvimo
Xolair
Adjuvant ALK+ NSCLC
HER2+ BC
PNH
2L+ DLBCL
2L+ DLBCL
DMD
RMS/PPMS
Stroke patients 4.5-24h
DME
DR
Food allergy
Ph III VERONA
Ph III ALINA
Ph I (pivotal)
Ph III COMMODORE 1/2
Ph III STARGLO
Ph III SUNMO
Ph III EMBARK
Ph III OCARINA II
Ph III TIMELESS
Ph III PAGODA
Ph III PAVILION
Ph III OUTMATCH
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Additional 2023 newsflow:
* Outcome studies are event-driven: timelines may change
Fenebrutinib: Positive Ph II (FENopta) results in RMS
• Elevidys US approval in DMD for 4 and 5 years old (Sarepta)
• Tiragolumab + Tecentriq + Avastin: Positive Ph I/II (MORPHEUS) results in 1L HCC
• Inavolisib + palbociclib + fulvestrant Ph III (INAVO120) data expected Q4 2023
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