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The FDA has granted a breakthrough therapy designation to tipifarnib for use in patients with recurrent or metastatic HRAS-mutated head and neck squamous cell carcinoma.
Search jobs 08-Jan-2021 U.S. FDA Approves Addition of Overall Survival and Other Secondary Endpoint Data to NUBEQA® (darolutamide) Prescribing Information Phase III data showed treatment with NUBEQA resulted in a 31% reduction in risk of death, with a statistically significant improvement in overall survival (OS) compared to placebo (HR=0.69, 95% CI 0.53-0.88; p=0.003), giving men with non-metastatic castration-resistant prostate cancer (nmCRPC) the opportunity to extend their lives 1 Time to pain progression, a key secondary endpoint, is meaningf...
AstraZeneca plc (LON:AZN)’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 submissi...
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 ...
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 L...