TAGRISSO Approved in the US for the Adjuvant Treatment of Patients With Early-Stage EGFR-mutated Lung Cancer
Approval based on unprecedented results from the ADAURA Phase III trial
where TAGRISSO
WILMINGTON, Del. (BUSINESS WIRE) AstraZeneca’s TAGRISSO
® (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent. TAGRISSO is indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
The approval was granted under the US Food and Drug Administration’s (FDA) Real-Time Oncology Review (RTOR) pilot program. Five other countries participated in a concurrent submission and review process through FDA’s Project Orbis.
ADDING MULTIMEDIA TAGRISSO Approved in the US for the Adjuvant Treatment of Patients With Early-Stage EGFR-mutated Lung Cancer
Approval based on unprecedented results from the ADAURA Phase III trial
where TAGRISSO
WILMINGTON, Del. (BUSINESS WIRE) AstraZeneca’s TAGRISSO
® (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumor resection with curative intent. TAGRISSO is indicated for EGFRm patients whose tumors have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
The approval was granted under the US Food and Drug Administration’s (FDA) Real-Time Oncology Review (RTOR) pilot program. Five other countries participated in a concurrent submission and review process through FDA’s Project Orbis.
AstraZeneca’s
Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent.
Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
The approval was granted under the US Food and Drug Administration’s (FDA) Real-Time Oncology Review (RTOR) pilot program. Five other countries participated in a concurrent submission and review process through FDA’s Project Orbis.
While up to 30% of all patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is still common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.
CoVepiT demonstrated generation of sentinel memory T cells with
long-term protective effect against COVID-19 in preclinical and human ex vivo studies
CoVepiT targets 11 virus proteins to prepare for potential mutations
Clinical trial expected to start in Q1 2021
OSE Immunotherapeutics committed to grant the French government a purchase option on doses of CoVepiT vaccine
NANTES, France, Dec. 18, 2020 (GLOBE NEWSWIRE)
OSE Immunotherapeutics (ISIN: FR0012127173; Mnemo: OSE) announces that the Company has obtained funding of €5.2 million under the PSPC-COVID call for projects, operated on behalf of the French government by Bpifrance as part of the
Programme d’investissements d’avenir (PIA) and led by the
OSE Immunotherapeutics Receives €5 2 M in Public Funding for the Clinical Development of CoVepiT, its Second Generation COVID-19 Vaccine wboc.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from wboc.com Daily Mail and Mail on Sunday newspapers.