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F Hoffmann-La Roche Ltd: FDA grants Priority Review to Roche s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

Priority Review recognises the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options1,2Additional analyses of INAVO120 will be presented in an oral

United statesSan antonioLevi garrawayBruno eschliLoren kalmKarsten kleineSabine borngrKirti pandeyYvette petillonBirgit masjostSimon goldsboroughSileia urechNathalie altermattRebekka schnellRoche groupHead of global product development

FDA grants Priority Review to Roche s inavolisib for

Priority Review recognises the best-in-class potential of the inavolisib-based regimen for patients in urgent need of new treatment options1,2Additional.

San antonioUnited statesKirti pandeyBirgit masjostSimon goldsboroughSabine borngrYvette petillonRebekka schnellSileia urechLevi garrawayKarsten kleineNathalie altermattLoren kalmBruno eschliNational cancer instituteHead of global product development

FDA grants Breakthrough Therapy Designation to Roche s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the.

United statesSan antonioBruno eschliSabine borngrNathalie altermattKarsten kleineSileia urechBirgit masjostLevi garrawayRebekka schnellKirti pandeyLoren kalmYvette petillonSimon goldsboroughNational cancer instituteHead of global product development

F Hoffmann-La Roche Ltd: FDA grants Breakthrough Therapy Designation to Roche s inavolisib for advanced hormone receptor-positive, HER2-negative breast cancer with a PIK3CA mutation

The designation is based on Phase III INAVO120 results, showing the inavolisib-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line

United statesSan antonioSileia urechSimon goldsboroughNathalie altermattBruno eschliLevi garrawayRebekka schnellKirti pandeyBirgit masjostLoren kalmSabine borngrKarsten kleineYvette petillonDrug administrationHead of global product development

FDA Grants Breakthrough Therapy Designation to Inavolisib for PIK3CA-Mutated Breast Cancer

Inavolisib was submitted to the FDA for review as a first-line treatment for advanced HR-positive, HER2-negative PIK3CA-mutated breast cancer.

Levi garrawayMayne pharma groupMayne pharma group limitedBreakthrough therapy designationPatients with breastPublished decemberPlus palbociclibFulvestrant improvesSystematic reviewDiagnostic workupIntj breastPatients withHormone receptor positiveLocally advancedMetastatic breast cancer

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